Sweden Job Openings

Mölnlycke Health Care

Quality System Engineer

Gothenburg

FULL TIME

November 19, 2024

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 a Quality System Engineer.


As a Quality System Engineer, you will be the first point of contact to receive, coordinate, and implement changes and improvements to the Master Control (Electronic Quality System Platform) , including the Document Module, NC/CAPA Module, Product Complaints, and any future modules/platforms. You will ensure an overall living Quality Management System by taking responsibility for the end-to-end process.



Key Accountabilities

  • Act as the first point of contact for change requests of Master Control.
  • Receive, log, and summarize requests to be handled in a defined governance structure.
  • Coordinate the onboarding of Mölnlycke sites to the Master Control Platform.
  • Ensure effective prioritization and usage of resources within QA and IT.
  • Assess and align changes/improvements to enable uniformity across the platform.
  • Liaise closely with IT and the vendor Master Control to implement improvements and best practices.


Key Decisions

  • Define and implement Master Control platform governance and take implementation and scheduling decisions.
  • Update associated quality system procedures, work instructions, etc., to ensure process alignment, simplification, and compliance.


Capabilities, Qualifications, and Experience

Capabilities:
  • Ability to communicate effectively across all levels of the organization.
  • Result-oriented and performance-driven with a strong customer-oriented and problem-solving mindset.
  • Team player, patient, and customer-focused.


Qualifications & Experience:

  • Academic background.
  • Experience in managing/maintaining an Electronic Quality System Platform such as Master Control.
  • Experience in working within Quality Assurance and Quality Management Systems. International experience preferred.
  • Experience in regulations and standards affecting Medical Device and pharma (recommended ISO13485, MDD/MDR, 21 CFR part 820).


Additional Responsibilities

  • Support quality improvement projects within the Global Quality Systems team.
  • Provide front and back room support during internal and external inspections/audits.
  • Support other QA IT activities as needed.
  • Be a member of the HQ internal audit team and complete scheduled internal audits.


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 Go Co 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.
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