Standardiseringsingenjör

Vi på Qiagen DNA Synthesis AB har i över 30 år producerat syntetiskt DNA för diagnostikändamål och är en del av det globala Qiagen med över 6 000 medarbetare i mer än 35 länder. Vår anläggning i Västerås har omkring 100 medarbetare och är certifierad enligt ISO ISO13485 samt att vi även jobbar i enlighet med 21 CFR Part 820. Nu söker vi en engagerad och erfaren EHS-ansvarig som kan driva vårt arbete inom miljö, hälsa och säkerhet och samtidigt vara en viktig del av vårt ledningsteam. Om Rollen Som EHS-ansvarig hos oss ansvarar du för att utveckla, implementera och följa upp våra rutiner och processer inom arbetsmiljö, miljö och säkerhet med både myndighetskrav och verksamhetsutveckling i fokus. Du leder interna och externa revisioner, genomför riskbedömningar och ser till att tillstånd och krav inom miljö, kemikaliehantering och brandskydd uppfylls. Rollen innebär att agera brandskyddsansvarig och ha direktkontakt med myndigheter i dessa frågor. Du kommer även att ha kontakt med kollegor inom EHS globalt och samarbeta med andra produktionsenheter inom Qiagen världen över. Detta innebär att du behöver trivas i en internationell kontext och vara van att kommunicera smidigt på engelska i både tal och skrift. Utöver det löpande säkerhetsarbetet driver du utbildningsinsatser, coachar kollegor och bygger en kultur där säkerhet och effektivitet inte är motsatser utan naturliga delar av vår vardag. Du leder genom andra, skapar delaktighet och visar att EHS är något vi gör tillsammans inte för att vi måste, utan för att vi vill. Ett starkt intresse och erfarenhet av Lean och operativ excellens är starkt meriterande, då rollen också omfattar att stötta förbättringsarbete i hela organisationen. Du kommer att arbeta nära både produktion, kvalitet och ledning och ha ett helhetsperspektiv som bidrar till såväl effektivitet som trygg arbetsmiljö. Din profil Du är en positiv kraft som engagerar och inspirerar andra genom ditt sätt att kommunicera. Med en pedagogisk ådra och förmåga att nå fram i både ord och handling skapar du delaktighet och bygger förtroende oavsett om det gäller medarbetare i produktion eller kollegor i ett globalt nätverk. Du kombinerar analytisk skärpa och integritet med ett genuint engagemang för säkerhet, hållbarhet och förbättringsarbete, och du trivs i en roll där du får ta ansvar och driva förändring tillsammans med andra. Vi ser gärna att du har relevant akademisk bakgrund t.ex. kemi, bioteknik, miljö eller liknande, erfarenhet från industriell verksamhet och vana vid att arbeta självständigt med både strategi och operativt genomförande. Du är van att samarbeta i internationella team, är trygg i både svenska och engelska och har lätt för att bygga relationer i hela organisationen. Tjänsten är placerad i Västerås. Om Qiagen I hjärtat av QIAGENs verksamhet finns en stark vision – att göra förbättringar i livet möjliga. Vi är på en spännande resa för att göra verklig skillnad inom vetenskap och hälsa. Även om vi vuxit till ett globalt företag har vi behållit vår entreprenöriella anda, och idag har vi storlek och styrka att driva viktiga initiativ världen över. Vår mest värdefulla tillgång är våra medarbetare – över 6 000 personer på mer än 35 platser runt om i världen. Vår ambition är att ha engagerade och exceptionella människor i de bästa teamen, och vi söker ständigt nya talanger som vill vara med på vår resa. Läs gärna mer www.qiagen.com  Vill du vara med och forma framtidens säkerhets- och förbättringsarbete i en global, växande och högteknologisk verksamhet? Då vill vi gärna höra från dig! Din ansökan Din ansökan registrerar du på www.norenlindholm.se eller genom knappen nedan, gärna så snart du kan, urval sker löpande. Frågor om tjänsten besvaras gärna av Marie Lindholm hos Norén & Lindholm på 070-77 88 156. Varmt välkommen till Qiagen

Our client is on a global transformation journey — and we’re looking for a skilled Mechanical Engineer Consultant to help implement Creo, Inventor, and Windchill across their business streams. You’ll join a central team, supporting the rollout of new CAD/PDM systems and ways of working. Your expertise will help shape product structures, workflows, training materials, and system integrations. Location: Southern part of Skåne, hybrid. QUALIFICATIONS & COMPETENCIES Been a part of a project changing CAD/PDM systems before Been a superuser in CREO/Windchill Open minded attitude and able to establish a positive change attitude in the Business Streams (end-users) Note that Windchill will not be “out of the box” so a high level of understanding processes is required since the software will be adapted (by the IT team) to fit the organization Able to support the Product Structure lead with input to modularization, attributes, templates etc. Able to support the Way of Working lead with User scenarios, User cases, workflows etc. Able to support the training material lead for CAD/PDM Highly skilled in working with Creo (and Inventor) and Windchill Background in mechanical engineering Able to drive activities independently and in a team Open-minded to new ways of working Communication skills An interest in systems and processes Strong English skills - both oral and written Valid EU work permit making you able to start working in Sweden right away AREA OF RESPONSIBILITY Be the go-to person during development and implementation Help to integrate the CAD, PDM and/or PLM systems within the organization Support the Product Structure lead with input to modularization, attributes, templates etc. Support the Way of Working lead with User scenarios, User cases, workflows etc. Support the training material lead for CAD/PDM INTERESTED? Please note that to apply for this position, you must go to our website. We are unable to process CVs sent directly to our email. If you have questions about the position, please contact us on: [email protected] The position will be closed when we have found the right candidate, and we encourage you to apply as soon as possible. Notice only your CV in English is necessary. Passionate about Engineering - RDT At RDT, our primary focus is our PEOPLE. We support our employees in professional and individual development. With our flat hierarchy, commitment and values, which inspire them to do their best. We pursue our PEOPLE’s work satisfaction and can guarantee highest quality, which leads to our second mission – our CLIENTS. We, our PEOPLE, provide engineering solutions that enable our customers to have a competitive advantage in efficiency, flexibility and costs. Thanks to our PEOPLE, we have supplied the best engineering services since 2007 and offer the best and most flexible terms in the market for engineering services. Be part of our missions and join RDT in Denmark and Sweden.

Job Overview & Purpose: The Director Clinical Portfolio Strategy reports to the Director Clinical Design and Strategies and is responsible for leading a team of Clinical Development Managers and Clinical Research Audiologists. The team will deliver Clinical Evidence Strategies, study designs, and study documentation for Cochlear product portfolios. This role will also provide subject matter expertise to product design and execute in-house clinical investigations to support business needs. The Director will bring clinical and scientific expertise into the portfolio domain, driving clinical science and understanding unmet clinical needs to contribute to commercial solutions and strategy definition. Additionally, the Director will be a key contributor to roadmap forward planning for the integration of emerging technologies. Key Responsibilities: Drive Clinical Evidence Strategy and Plan: * Lead a team to develop a comprehensive Clinical Evidence Strategy and Plan (CESP) for products and systems within the Portfolio area. * Ensure processes and forums exist to communicate CESPs and planned evidence activities. * Assimilate key inputs from Clinical and represent the function as the consistent point of contact for the Portfolio. * Develop, maintain, and communicate scenario plans for the Portfolio. * Close knowledge gaps through literature reviews, data collation, and analyses. Maintain and Enhance Cross-Functional Collaboration: * Promote a culture of cross-functional collaboration as input to clinical strategy and product design. * Partner with GSM to contribute to desired claims and evidence needs to support key markets. * Work in partnership with R&D to ensure Clinical representation and input at appropriately defined timepoints and milestones throughout the Product Innovation Process (PIP). Lead Development of End-to-End Evidence Strategy: * Lead the development of an aligned end-to-end strategy for the evolution of the Acoustics portfolio. * Ensure efficient and effective transfer of evidence and knowledge from Advanced Innovation to the Portfolio. * Drive the clinical science for the portfolio, identify gaps and ambiguity in knowledge and evidence. Drive Planning and Delivery of Overall Portfolio Strategy: * Plan at Portfolio level to ensure appropriate resource allocation. * Oversee and develop study documentation to ensure compliance with GCP and business processes. * Lead or support the team in discussions with internal stakeholders to develop study design concepts. Effectively Communicate Clinical Plans: * Communicate and advocate for the lifetime portfolio strategy across cross-functional project teams. * Ensure that the clinical portfolio strategy and research priorities are well understood and aligned with the needs of the evidence to be gathered and the studies to be undertaken. Integrate Clinical Audiology and Clinical Portfolio Functions: * Ensure team members are allocated to projects in line with their expertise and business needs. * Identify gaps and opportunities for the Clinical Audiology function to optimally support product design. * Strengthen networks and communication mechanisms between CSI Clinical Audiology teams and regional audiology and ClinTech teams. Team Role: * Actively promote the quality management system and ensure that all staff are trained. * Build capability of people managers and their teams to attract, develop, and retain top talent. * Demonstrate WH&S leadership and ensure that people are suitably trained to perform jobs effectively and safely. Minimum Key Incumbent Requirements: * 10 years of experience in clinical research within the medical device sector or relevant field. * Demonstrable exposure to commercial business needs and experience in balancing needs of internal stakeholders. * An Enterprise mindset with the ability to see the "big picture". * Resilient, resourceful, and solutions-oriented. * Demonstrated ability in managing people and creating a positive working environment. Desired Skills: * Bachelor degree or higher in a scientific or healthcare discipline. * Experience in development of clinical strategies and in study design and reporting. * Thorough understanding of international aspects of device development process. * Familiar and comfortable with FDA, TUV Sud or equivalent Notified Body, and TGA regulations. * Clear and effective communicator with well-developed report and technical writing skills. * Familiar with data management and interpretation methods. * Comfortable with regular travel as deemed appropriate. Certifications: * PhD or tertiary qualification in Audiology. * Experience in hearing care setting or industry. * Leadership of a globally dispersed clinical research team in either pharmaceuticals or medical devices. * Familiar and comfortable with clinical concepts and practices in the field of hearing. Education: * PhD or tertiary qualification in Audiology. Languages: * English - Fluent.

With a combination of research and development, UMS Skeldar offers an advanced helicopter platform for the defence industry and civil security. Together we create a culture focusing on Communication, Trust and Commitment. We like to do fun things together and we know that our team is our greatest asset. Here, our employees are encouraged to constantly develop and grow to their full potential. We are excited being able to strengthen our Quality team within the department of Product and Compliance. With this we will secure a continuous development and improvement of our quality management work. As a Quality Engineer, your primary responsibilities will include ensuring that both internal and external requirements are met according to our standards (e.g. EN9001 and EN9100). You will develop and improve processes, conduct quality inspections, and perform internal controls and audits in production and manufacturing, as well as external audits at our sub-suppliers. You will also work with performing FMEA. In the role as a Quality Engineer, you will (besides the above): Work within the entire production flow to ensure that internal and external components, processes, and finished products meet the set requirements Be responsible for and develop the incoming goods inspection process Be responsible for the quarantine and lead quality investigations Does it sound interesting? Apply today! Are you the one we are looking for?In the role of Quality Engineer, we are looking for an accurate person who is driven by delivering with high quality. We are looking for you with the ability to cooperate well with both colleagues and external parties. You are not afraid to take on new work tasks and can solve and manage tasks on your own. You like solving and analysing problems to understand the long-term consequences. To succeed in this role, we see that you have a university degree within engineering or relevant area as well as relevant work experience. It is preferable if you have experience of Quality Management Systems. It is an advantage if you have experience from manufacturing companies where you have worked actively to pursue quality issues. The position requires both English and Swedish in speaking and writing. We offer: an opportunity to be part of a dynamic company that is constantly developing, where your influence plays an important role high tech and market leading product in the unmanned industry a familiar work culture characterized by spirit of cooperation and high commitment activities that promote both social community and health, through our Party Committee, Health Committee, Board Games Committee and a Women's Network. More information: Workplace: Linköping. Type of employment: Full-time. Start: Immediately with regard to notice period. Travel: Travels domestic as well as internationally will occur. For employment within UMS Skeldar, it is required that you will be approved in accordance with the Swedish Protective Security Act. For some roles with certain security-sensitive activities it may require certain citizenship. We process applications on an ongoing basis. We look forward to your application! Key words: Kvalitetsingenjör, Process Quality Engineer, Quality Specialist, FMEA, ISO9001

UMS Skeldar är ett mångfacetterat företag med förmågor inom forskning, utveckling, design, tillverkning, testning, utbildning, konsultande, underhåll och mycket mer. Vi utvecklar en av världens mest avancerade Unmanned Aerial Vehicle (UAV). Bli en del av vårt starka team! Du kommer att bli en del av ett team som genomför stora delar av de driftsäkerhetsanalyser som bidrar till att våra tekniska system uppfyller kraven för tillgänglighet, tillförlitlighet och underhållsmässighet. Detta handlar om allt från delprojektledning till implementering av ändringar i underhållskonceptet både inom nyutveckling och eftermarknad. Som Support/ILS-ingenjör kommer du att få arbeta med de flesta av elementen inom integrerat logistikstöd, eller Integrated logistic support. Exempel på arbetsuppgifter är underhållsanalyser, reservdelsberedning, teknisk dokumentation, genomförande av driftsäkerhetsanalyser, process/metodförändringar och konfigurationshantering. I rollen som Support/ILS-ingenjör kommer du att: Agera spindeln i nätet mellan design- och supportorganisationen Upprätta reservdelslistor och andra centrala supportdokument Söka och analysera information på egen hand samt tillsammans med våra utvecklingsingenjörer Arbeta med befintliga dokument för att tillse att de håller gällande standarder Hantera nya krav på våra tekniska dokument Låter tjänsten intressant? Tveka inte att söka redan idag! Är du den vi söker?Vi lägger stor vikt vid personliga egenskaper och för att du ska trivas så bra som möjligt söker vi efter dig som är initiativtagande, strukturerad, kvalitetsmedveten och har en god samarbetsförmåga. För att lyckas i den här rollen ser vi att du har en relevant universitetsutbildning samt några års arbetslivserfarenhet. Vi förutsätter att du har erfarenhet av arbete med underhållsanalyser, produktsupport och systematiskt kvalitetsarbete. Tjänsten ställer höga krav på såväl engelska som svenska i tal och skrift. Vi erbjuder: en möjlighet att vara en del av ett dynamiskt företag som ständigt utvecklas, där din påverkan spelar en viktig roll en högteknologisk produkt som just nu ligger i framkant på marknaden en familjär arbetskultur som karaktäriseras av samarbete och högt engagemang aktiviteter som främjar både social gemenskap och hälsa, genom vår Festkommitté, Hälsokommitté, Brädspelskommitté och ett Kvinnligt Nätverk. Ytterligare information: Arbetsplats: Linköping Tjänstgöringsgrad: Heltid Start: Omgående med hänsyn till uppsägningstid Resor: Kan förekomma i tjänsten För en anställning hos oss på UMS Skeldar krävs att du genomgår och godkänns enligt vid var tid gällande bestämmelser för säkerhetsskydd. Roller där vi har krav på säkerhetsklassinplacering kan, i förekommande fall, medföra krav på visst medborgarskap. Vi behandlar ansökningar löpande. Vi ser fram emot din ansökan! Key words: ILS engineer, ILS ingenjör, Support engineer, Logistics Engineer, Underhållssystem, Integrerat logistikstöd, UAV

With a combination of research and development, UMS Skeldar offers an advanced helicopter platform for the defence industry and civil security. Together we create a culture focusing on Communication, Trust and Commitment. We like to do fun things together and we know that our team is our greatest asset. Here, our employees are encouraged to constantly develop and grow to their full potential. You become part of the Product & Compliance departmentconsisting of for example Systems Engineers, Configuration Managers and Requirement Engineers. We are now looking for a System Safety Engineer that can help us take the next steps in ensuring compliance with the latest regulatory and safety requirements. In the role as System Safety Engineer you will: perform system safety analysis for our Unmanned Aircraft System (UAS) identify safety critical functions and components assist system engineers in the design work to meet system safety requirements develop safety mitigation strategies together with system engineers keep up to date on relevant regulations in the industry. Initiate and drive appropriate plans and actions develop processes and best practices in the area of systems safety Does it sound interesting? Apply today! Are you the one we are looking for? We place great importance on personal qualities for you to thrive in the role. We are looking for you who have the ability to collaborate, are self-propelled and a problem solver. To succeed in this role, we see that you have a university degree in aerospace engineering or other relevant engineering discipline. As well as a minimum of 5 years of working experience in systems safety work within aerospace industry. Experience from working in unmanned and/or helicopter industry is meritious. The position requires both English and Swedish in speaking and writing. We offer: • an opportunity to be part of a dynamic company that is constantly developing, where your influence plays an important role• high tech and market leading product in the unmanned industry • a familiar work culture characterized by spirit of cooperation and high commitment• activities that promote both social community and health, through our Party Committee, Health Committee, Board Games Committee and a Women's Network. Workplace: LinköpingType of employment: Full-timeStart: Immediately with regard to notice periodTravel: Occurs in the service For employment within UMS Skeldar, it is required that you will be approved in accordance with the Swedish Protective Security Act. For some roles with certain security-sensitive activities it may require certain citizenship. We process applications on an ongoing basis. We look forward to your application! Key words: System Safety, Systemsäkerhet, System Safety Engineer, UAV, RPAS, Requirements

With a combination of research and development, UMS Skeldar offers an advanced helicopter platform for the defence industry and civil security. Together we create a culture focusing on Communication, Trust and Commitment. We like to do fun things together and we know that our team is our greatest asset. Here, our employees are encouraged to constantly develop and grow to their full potential. You become part of the Product & Compliance departmentconsisting of for example Systems Engineers, Configuration Managers and Requirement Engineers. We are now looking for a System Safety Engineer that can help us take the next steps in ensuring compliance with the latest regulatory and safety requirements. In the role as System Safety Engineer you will: perform system safety analysis for our Unmanned Aircraft System (UAS) identify safety critical functions and components assist system engineers in the design work to meet system safety requirements develop safety mitigation strategies together with system engineers keep up to date on relevant regulations in the industry. Initiate and drive appropriate plans and actions develop processes and best practices in the area of systems safety Does it sound interesting? Apply today! Are you the one we are looking for? We place great importance on personal qualities for you to thrive in the role. We are looking for you who have the ability to collaborate, are self-propelled and a problem solver. To succeed in this role, we see that you have a university degree in aerospace engineering or other relevant engineering discipline. As well as a minimum of 5 years of working experience in systems safety work within aerospace industry. Experience from working in unmanned and/or helicopter industry is meritious. The position requires both English and Swedish in speaking and writing. We offer: an opportunity to be part of a dynamic company that is constantly developing, where your influence plays an important role high tech and market leading product in the unmanned industry a familiar work culture characterized by spirit of cooperation and high commitment activities that promote both social community and health, through our Party Committee, Health Committee, Board Games Committee and a Women's Network Workplace: LinköpingType of employment: Full-timeStart: Immediately with regard to notice periodTravel: Occurs in the service For employment within UMS Skeldar, it is required that you will be approved in accordance with the Swedish Protective Security Act. For some roles with certain security-sensitive activities it may require certain citizenship. We process applications on an ongoing basis. We look forward to your application! Key words: System Safety, Systemsäkerhet, System Safety Engineer, UAV, RPAS, Requirements

Job Overview: We are seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our team. This role is crucial in providing regulatory support throughout the lifecycle of Cochlear products. The Senior Regulatory Affairs Specialist will work closely with R&D cross-functional project teams, sustaining engineering, and manufacturing groups to ensure compliance with regulatory requirements. Key Responsibilities: * Regulatory Strategy and Planning: Support project teams with regulatory and standards compliance advice through product development. Define documentation needs and ensure they are delivered to quality and timeline requirements. Develop regulatory strategies in collaboration with regional regulatory teams, to support business plans for products or projects. Participate in strategic regulatory and continuous improvement projects as required. * Regulatory Submissions and Related Activities: Prepare and manage the submission process to gain new or modified product approvals and maintain product licenses. Adapt or create technical dossiers for regional market submissions and coordinate support for regional subsidiaries, offices, and distributors. Ensure timely regulatory assessments of sustaining changes, including submissions or the necessary documentation of them (e.g. Letter to File). * Cross-Functional Regulatory Direction: Evaluate labeling and manufacturing changes and promotional material for regulatory impact. Provide regulatory direction to the business and inform the organization about new or changing national regulations/trends and propose implementation plans. Drive the implementation of better regulatory practices and processes. Qualifications: * Proven experience in regulatory affairs, including management, compilation, submission, and maintenance of regulatory filings. * Strong skills in influencing in a matrix team environment and managing stakeholders at all levels within the business. * Ability to make judgments and provide advice that balances business interests and regulatory risk. * Excellent review, report writing and documentation skills. * Knowledge of global regulatory requirements and regulations for medical devices, with an emphasis on MDR. Certifications: * Regulatory Affairs Certification (RAC) is highly desirable. Education: * Minimum Bachelor's degree in engineering, legal, scientific, or healthcare; or 3+ years' experience in software or product development, quality, and/or regulatory affairs. Languages: * English - Advanced/Fluent. Work Experience: * 3+ years' experience in regulatory affairs, including a track record of management, compilation, submission, and maintenance of regulatory filings. * 3+ years' experience in medical devices product or software development (SaMD). * Ideally worked in a global matrix organization including manufacturing and logistics.

With a combination of research and development, UMS Skeldar offers an advanced helicopter platform for the defence industry and civil security. Together we create a culture focusing on Communication, Trust and Commitment. We like to do fun things together and we know that our team is our greatest asset. Here, our employees are encouraged to constantly develop and grow to their full potential. You become part of the Product & Compliance departmentconsisting of for example Systems Engineers, Configuration Managers and Requirement Engineers. We are now looking for a System Safety Engineer that can help us take the next steps in ensuring compliance with the latest regulatory and safety requirements. In the role as System Safety Engineer you will: perform system safety analysis for our Unmanned Aircraft System (UAS) identify safety critical functions and components assist system engineers in the design work to meet system safety requirements develop safety mitigation strategies together with system engineers keep up to date on relevant regulations in the industry. Initiate and drive appropriate plans and actions develop processes and best practices in the area of systems safety Does it sound interesting? Apply today! Are you the one we are looking for? We place great importance on personal qualities for you to thrive in the role. We are looking for you who have the ability to collaborate, are self-propelled and a problem solver. To succeed in this role, we see that you have a university degree in aerospace engineering or other relevant engineering discipline. As well as a minimum of 5 years of working experience in systems safety work within aerospace industry. Experience from working in unmanned and/or helicopter industry is meritious. The position requires both English and Swedish in speaking and writing. We offer: an opportunity to be part of a dynamic company that is constantly developing, where your influence plays an important role high tech and market leading product in the unmanned industry a familiar work culture characterized by spirit of cooperation and high commitment activities that promote both social community and health, through our Party Committee, Health Committee, Board Games Committee and a Women's Network Workplace: LinköpingType of employment: Full-timeStart: Immediately with regard to notice periodTravel: Occurs in the service For employment within UMS Skeldar, it is required that you will be approved in accordance with the Swedish Protective Security Act. For some roles with certain security-sensitive activities it may require certain citizenship. We process applications on an ongoing basis. We look forward to your application! Key words: System Safety, Systemsäkerhet, System Safety Engineer, UAV, RPAS, Requirements