Quality Engineer, Part Production – Medical Devices

6 days ago

Lynge, Allerød Kommune, Denmark WSA Full time 80,000 - 120,000 per year

At WSA, we combine deep audiological insight with advanced engineering to create hearing solutions that truly make a difference. Our work bridges science and technology—translating complex challenges into meaningful user experiences that improve people's lives.

As part of our Operations and Business Quality organization, you'll join a global team dedicated to ensuring that every product leaving our facilities meets the highest standards of quality, safety, and compliance. If you're motivated by precision, process improvement, and helping to ensure product excellence in a highly regulated environment, you'll find purpose and challenge here at WSA.

The Team

The Business Quality team plays a key role in ensuring that our medical devices meet all applicable quality and regulatory requirements. Working closely with production, R& D, NPI, engineering, and regulatory colleagues, we monitor compliance, resolve quality issues, and drive continuous improvement initiatives across the production line.

Our work is guided by regulatory frameworks such as ISO 13485, FDA QSR (21 CFR Part 820), and EU MDR, ensuring that each product we deliver is safe, effective, and reliable. Collaboration is central to what we do — every improvement, no matter how small, helps us deliver better outcomes for people who rely on our hearing solutions.

What you will do

As a Quality Engineer in Part Production, you will play a key role in maintaining product and process quality, managing nonconformances, and leading corrective and preventive actions. Your main responsibilities will include:

  • Analyzing quality data and trends to identify opportunities for continuous improvement and process optimization.
  • Maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and EU MDR requirements.
  • Supporting internal and external audits and regulatory inspections.
  • Overseeing in-process and final inspections, product release, and adherence to GMP standards.
  • Investigating and documenting production nonconformances (NCMRs), performing root cause analyses, and recommending dispositions.
  • Leading CAPA investigations to address systemic issues and ensure timely closure.
  • Supporting process validation (IQ/OQ/PQ), Test Method Validation (TMV), and risk assessments .
What you bring

We imagine that you hold a degree in Engineering (Mechanical, Electronics, or a related field) and bring several years (5+) of experience in Quality Assurance or Quality Engineering within the medical device industry.

Experience

  • Strong knowledge of ISO 13485, FDA QSR, EU MDR, .
  • Hands-on experience with NC and CAPA processes.
  • Familiarity with statistical tools (SPC, Six Sigma) and problem-solving methods such as 5-Why and Fishbone analysis.
  • Excellent communication skills in English (Danish is an advantage).
  • It would be an advantage if you also have experience with electronic QMS tools, packaging validation, or hold a Certified Quality Engineer (CQE) certification.

Personal competencies

  • Self-driven and proactive, with a strong sense of ownership and accountability
  • Confident in making decisions and taking initiative in a regulated environment
  • Skilled at driving change and improving processes through a solution-oriented mindset
  • Creative and analytical thinker who approaches challenges from new perspectives
  • Independent and well-organized, yet highly collaborative across teams and locations
  • Clear and open communicator who builds trust and alignment with stakeholders

Who we are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.

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