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    QA Product Development Engineer - Gothenburg, Sverige - Mölnlycke

    Mölnlycke
    Mölnlycke Gothenburg, Sverige

    för 6 dagar sedan

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    Beskrivning

    Advance performance, transform lives

    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.

    Mölnlycke is now looking for a new QA Product Development Engineer to join us. This position will be placed at our global HQ in Sweden, Gothenburg.

    As a QA Product Development Engineer at Mölnlycke, the core of the role is to:

    Pro-actively support and advice Mölnlycke's business areas and functions in design control and change control activities according to our quality management system (QMS)
  • Support the organization in addressing quality issues that can jeopardize compliance to product development and life cycle management processes (Design Control, Change Control, Risk Management, Post Market Surveillance or related processes)
  • Support the QA Process managers and process owners for product development and life cycle management processes in the implementation, maintenance and continuous improvement of the quality management system (QMS) in alignment with applicable internal and external policies, standards and regulations.

    • Your main tasks include:

  • Ensuring that Design Control, Change control and risk management processes are followed during product development projects and product changes
  • Provide feedback on the applicability and adherence to QMS processes during execution of new product development projects and life cycle management activities within the areas of Design Control, Change Control, Risk Management, Post-Market surveillance and related sub-processes.
  • Review, approve or reject relevant product related technical documentation for completeness and compliance according to QMS requirements and applicable regulations
  • Support in root cause analysis of quality issues for design or change control, as well as giving input to effective corrections, corrective and preventive actions
  • Lead smaller scale change projects
  • Function as source/reference point for quality information and coach stakeholders in QMS requirements
  • When applicable participate in external, corporate, and internal audit activities to support audit programs.
  • Ensure right QA competence involvement at the right time in design control or change control related activities and questions

    • What you'll get
    Wellness benefits
    Flexible working hours
    Great colleagues in a global company
    An open, friendly and fair working atmosphere
    Competitive compensation package including company pension plan, bonus, company health care

    What you'll need

  • Academic background in engineering, life sciences, medical biology, chemical area or other relevant area
  • Minimum 5 years of experience from medical device industry or equivalent
  • Working experience in Product Development/Lifecycle Management area, preferable within the areas of Quality or R&D
  • Knowledge in applicable quality system regulation and standards, ISO 13485, MDD/MDR, FDA 21 CFR part 820 and ISO 9000
  • Experience from work in an international organization or environment
  • Full professional proficiency in English
  • Strong communication skills, accompanied by a flexible mindset and creativity

    • Your work-life balance

    Hybrid policy

    Full-time position

    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 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. For more information, please visit and

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