Mölnlycke Health Care AB jobb

Lediga jobb hos Mölnlycke Health Care AB

eQMS Product Owner
Mölnlycke Health Care AB
Systemförvaltare m.fl.

Make your next step a big one! Grow your career in an international environment at Mölnlycke. Do you want your impact to be recognized? Join us and make a difference. About the Job Are you ready to challenge yourself in a new environment and have a real impact? Mölnlycke is now looking for an eQMS Product Owner. As an eQMS Product Owner, you will be responsible for the maintenance and continuous improvement of the electronic quality management system (eQMS). This role ensures the effective implementation and rollout of key modules, including document control, non-conformance/corrective and preventive actions (NC/CAPA), and training across multiple locations. The role will also coordinate various quality system processes to support organizational compliance and quality objectives. Key Accountabilities Maintenance and Improvement of eQMS: Ensure the eQMS is up-to-date, functional, and aligned with regulatory requirements and industry best practices. Module Rollout: Lead the deployment of eQMS modules (document control, NC/CAPA, training) from headquarters to manufacturing, sales and warehousing sites, ensuring smooth implementation and user adoption. Process Coordination: Coordinate and support other quality system processes as needed, including audits, inspections, and quality reviews. Training and Support: Provide training and ongoing support to users of the eQMS to ensure effective utilization and compliance. Continuous Improvement: Identify opportunities for process improvements within the quality system and lead initiatives to enhance efficiency and effectiveness. Collaborate closely with eQMS supplier to enable optimal solution for Mölnlycke Support KPI Dashbord: Support development, implementation and maintenance of global KPI dashboards in Power BI. Key Decisions System Enhancements: Determine/coordinate necessary updates and enhancements to the eQMS to improve functionality and compliance. Implementation Strategies: Support the development and execute strategies for the successful rollout of eQMS modules to various locations. Training Programs: Support and implement training programs to ensure all users are proficient in using the eQMS. Issue Resolution: Address and resolve issues or challenges related to the eQMS and its modules. Process Improvements: Coordinate process improvements and lead initiatives to enhance the overall quality system. Capabilities, Qualifications, and Experience Capabilities: Ability to communicate effectively across all levels of the organization. Result orientated and performance driven with a strong customer oriented and problem-solving mindset. Team player, patient and customer focused. Qualifications & Experience: Experience in maintaining a eQMS a distinct advantage. Experience in rolling out global systems across an organisation a distinct advantage. Experience in Project Management a distinct advantage. Experience in working within Quality assurance, Quality Management Systems a distinct advantage. Experience in creating global KPI dashboards in Power BI a distinct advantage. Experience in regulations and standards affecting Medical Device and pharma (recommended ISO13485, MDD/MDR, 21 CFR part 820) a distinct advantage. Additional Responsibilities Provide front and back room support during internal and external inspections/audits. Support other QA IT activities as needed. Your Growth and Development At Mölnlycke, training is important, as well as the experiences you have and the colleagues around you. You’ll have a variety of opportunities to stretch yourself and develop new skills. We’ll give you the challenges, skills, and support to advance your career. What You’ll Get Location-specific benefits Wellbeing initiatives What You’ll Need Relevant qualifications and experience as outlined above. Your Work-Life Balance Flexible or hybrid working options. Travel required as needed. Full-time position. Our Approach to Diversity and Inclusion We strive to have a diverse mix of people from different cultures, ages, geographies, and genders, to reflect the world in which we operate and to facilitate innovative thinking across the business. About Mölnlycke Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical, and economic outcomes. Our business is organized in four business areas: Wound Care, Operating Room Solutions, Gloves, and Antiseptics, where customer centricity, sustainability, and digitalization are at the heart of everything we do. Mölnlycke employs around 8,700 people. The company headquarters are in Gothenburg, Sweden, and we operate in more than 100 countries worldwide. Mölnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health, and in early 2025, our headquarters will move there. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies founded by the Wallenberg family in 1916. For more information, please visit www.molnlycke.com and www.molnlycke.com/careers

2 dagar sedan
Sista ansökan:
14 februari 2025
Quality & Regulatory Project Manager
Mölnlycke Health Care AB
Övriga administrations- och servicechefer

Help us make breakthrough innovations in healthcare! Do you want a career that impacts millions of people for the good? At Mölnlycke, you’ll be helping to equip medical professionals with solutions to improve outcomes for patients. And you’ll develop your career in a growing organization with an inspirational culture – where you’ll be recognized for the results you’ve achieved. The Quality Assurance (QA) department orchestrates One Mölnlycke to provide our customers with world-leading medical solutions by assuring Quality and Compliance efficiently throughout the life cycle of our products. We aspire to make Quality an instinctive choice for everyone, every day at Mölnlycke. QA interacts closely with the different business areas and global functions to ensure required quality support and compliance for New Product Development, Life Cycle Management, Operations, and Commercial activities. About the job As a Quality & Regulatory Project Manager, you will be responsible for managing complex projects and stakeholder groups, coordinating activities within Quality and Regulatory teams, and delivering projects through strategic planning, execution, and closure. You will represent the quality and regulatory functions and drive related topics in key project meetings. Key Responsibilities Organize and coordinate projects using proper project management tools. Use data to generate information to steer projects and provide evidence of improvements. Create and manage Quality and Regulatory plans, timelines, and responsibility matrices in alignment with process owners through cross-functional discussions. Ensure overall project plans align with QA/RA timelines provided by process owners. Plan, track, and monitor project activities with QA/RA process owners to maintain targeted submission dates. Partner with stakeholders to prioritize and execute projects appropriately. Identify problems, forecast risks, and proactively seek resolutions. Communicate effectively about projects and activities at different organizational levels. Provide guidance to Quality and Regulatory teams on uploading submission documents to the PLM system. Lead improvement activities, establishing repeatable and efficient processes adjusted to business needs. As a process owner, ensure effective and compliant execution of quality system processes, including nonconformance, CAPAs, complaints, and change controls. Constantly evaluate the suitability of the QMS to applicable quality and regulatory standards. What you'll need 5+ years of experience in the medical device industry within Quality and/or Regulatory departments. 10+ years of project and change management experience. Working knowledge of Technical Documentation. Excellent organizational and management skills. Excellent written and oral communication skills, capable of delivering key communication with clarity and impact. Strong presentation skills. Excellent interpersonal and negotiation skills, with the ability to build networks and secure appropriate support and outcomes for projects. A constant focus on improving performance and excellence in all tasks. Problem-solving skills. Fluency in English, both written and spoken. Bachelor's degree in Sciences. What you'll get Flexible working hours and a hybrid work-from-home policy. An attractive package including an annual bonus, pension, health insurance, and other benefits. Great opportunities to grow and develop within your role and in the organization. A great network of talents and colleagues at a diverse global company with an open, friendly, and fair working atmosphere. The opportunity to make a positive impact on the healthcare sector by contributing to digital solutions for customers and healthcare professionals. Our approach to diversity and inclusion At Mölnlycke, diversity is not just a vision, but our strength. We are dedicated to fostering an inclusive workplace that values and celebrates the power of diversity. At the heart of our commitment is the belief that diversity fuels innovation, creativity, and problem-solving. We invite you to be a part of a team where authenticity is embraced, and every employee, regardless of background or any other traits, experiences a true sense of belonging. Your attitude, drive, enthusiasm, and eagerness to learn are just as important to us as the requirements for the role. About Mölnlycke Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical, and economic outcomes. Our business is organized in four areas: Wound Care, Operating Room Solutions, Gloves, and Antiseptics, with customer centricity, sustainability, and digitalization at the heart of everything we do. Mölnlycke employs around 8,400 people. The company headquarters are in Gothenburg, Sweden, and we operate in more than 100 countries worldwide. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality global companies founded by the Wallenberg family in 1916. For more information, please visit www.molnlycke.com and www.molnlycke.com/careers.

2 dagar sedan
Sista ansökan:
14 februari 2025
Global Manufacturing Excellence Manager
Mölnlycke Health Care AB
Civilingenjörsyrken inom maskinteknik

Do you want your impact to be recognized? Do you want a career that impacts millions of people for the good? At Mölnlycke, you’ll be helping to equip medical professionals with solutions to improve outcomes for patients. And you’ll develop your career in a growing organisation with an inspirational culture – where you’ll be recognised for the results you’ve achieved. To further invest in our sustainable future, we are now looking for a Global Manufacturing Excellence Manager to join us. This role requires you to travel approximately 50 % of your working time, primarily within Europe with occasional trips to Asia. This position can be based at one of our key locations; Gothenburg (Global HQ), Czech Republic, Belgium or Germany. Key Responsibilities: Provide Technical Support: Assist Mölnlycke production sites and other locations on an ad hoc basis while implementing the Mölnlycke Production System (MPS) aligned with LEAN principles. Strategic Planning: Support sites in designing and updating their MPS implementation plans. Implementation & Deployment: Guide and follow up with sites during implementation activities and deployment of MPS initiatives. Program Development: Coordinate and contribute to the development of the MPS program pillars’ framework and related capabilities. What you’ll do Foster a problem solving culture, starting from performances review process at each organizational level (train/coach/challenge/follow up) Foster and role model Lean Leadership Take part as requested of the E2E Value Stream Analysis process (together with local Manufacturing Excellence Managers) Coordinate, support, physically implement and follow up designated sites improvement activities (kaizen) and projects Remain up to date in term of Lean Thinking and methodologies Make best use of the Mölnlycke Production System framework and to contribute to its development Provide specific knowledge via coaching and training to key sites stakeholders Maintain strong connection with the shopfloor (be visible and available, be engaged where value is created) What you’ll need Extensive experience in implementing and managing Lean Activities in a manufacturing company Preferred Engineering degree or equivalent background Manufacturing related experiences (exposure to shopfloor working environment) Change Management experience English (written/spoken) proficiency Meritorious Experience Project management experience Personal Competencies Problem Solving skills Leadership skills Influencing skills Facilitating skills Result Orientation Customer Orientation Teamworking attitude What you’ll get Competitive compensation package including company pension plan, bonus, company health care Flexible working hours and wellness benefits Great colleagues in a global company An open, friendly and fair working atmosphere Your work-life balance Hybrid working policy Full-time position Our approach to diversity and inclusion At Mölnlycke diversity, equity and inclusion is not just a vision, but our strength. We are dedicated to fostering an inclusive workplace that values and celebrates the power of diversity. At the heart of our commitment is the belief that diversity fuels innovation, creativity, and problem-solving. We invite you to be a part of a team where authenticity is embraced, and every employee, regardless of background or any other traits, experiences a true sense of belonging Your attitude, drive, enthusiasm, and eagerness to learn are just as important to us as the requirements for the role. Please submit your application at earliest convenience, we are reviewing candidates continuously. About Mölnlycke Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. Our business is organised in the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalisation are at the heart of everything we do. Mölnlycke employs around 8,700 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Mölnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health, and in early 2025 our headquarters will move there. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916.

29 dagar sedan
Sista ansökan:
18 januari 2025