Medical Device Assurance Specialist with Global Impact
2 days ago
We are seeking a highly skilled QA Design Assurance Specialist to join our team in Glostrup, Denmark.
The successful candidate will be responsible for ensuring compliance with internal and external requirements during design and development of new products, particularly in design control, risk management, V&V activities, and change control.
About the Role- Provide guidance on design control activities to identify innovative solutions that meet both business needs and quality standards.
- Conduct reviews and approvals of design control documents, design changes, nonconformances, CAPAs.
- Drive quality initiatives to support continuous improvements of our processes.
Additional responsibilities may include:
- Product investigation support
- Support of internal and external audits
- Support for regulatory submissions and filings
- May initiate and support Quality Management Systems (QMS) improvements within area of responsibility
- Provide expertise, guidance, and training within area of responsibility to the organization
The QA Design Assurance Specialist will report to the Manager, Development QA.
Requirements- Master's degree in biotechnology, Engineering, or related field of study.
- Preferably +4 years of experience in development of In Vitro Diagnostics (IVD), Medical Devices, and/or Pharmaceuticals.
- Experience within both reagents, hardware, and software devices is preferred but not required.
- Proficient in Quality System Standards (ISO13485, FDA CFR21 Part 820, MDSAP) and IVD/Medical Devices legislation in EU and USA.
- Business-oriented and a desire to work in a dynamic and adaptable environment.
- Strong analytical skills with focus on finding right solutions in compliance with regulations.
- Excellent communication and collaboration skills.
- Ability to make independent decisions/complete tasks within framework and guidelines of the organization at scheduled time.
- Full fluency in English on business level. Note that fluency in Danish is not required but preferable.
Our salary range for this position is between €60,000 - €80,000 per annum, depending on location and individual qualifications.
We offer an inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing, and product quality activities.
A role among passionate colleagues, in a growth-oriented and inclusive environment, where you will become part of a caring and fast-paced environment, built on integrity, sharing, and trust.
We also offer core global benefits, including Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Physiotherapy, and much more.
About UsWe are a world-class company that takes pride in developing new innovative solutions for pathology labs around the world to improve cancer diagnostics.
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