Senior QA Design Assurance Specialist
Agilent TechnologiesJob Description
Are you experienced within design control of medical devices and interested in making a difference in cancer diagnostics worldwide?
At our site in Glostrup we develop and produce reagents, instruments and software for in vitro diagnostic of cancer, and we are currently looking for a Senior QA Design Assurance Specialist to work primarily on our instrument solutions supporting both sustaining activities and development projects.
The Senior QA Design Assurance Specialist will be responsible for ensuring compliance with internal and external requirements, especially with regards to design control, including e.g. requirements, risk management, V&V activities and change control.
The Senior QA Design Assurance Specialist will represent QA on various project teams and partner with local/international stakeholders across the organization, covering but not limited to R&D, RA, Procurement, Service and Marketing.
The focus will be to:
- Provide guidance to stakeholders on design control activities to identify innovative and efficient solutions on a wide range of quality topics which meet both business needs and the right level of quality.
- Conduct reviews and approvals of design control documents, design changes, nonconformances, CAPAs.
- Provide expertise, guidance and training within area of responsibility to the organization.
- Drive quality initiatives to support continuous improvements of our processes.
Additional responsibilities may include:
- Product investigation support.
- Support to internal and external audits.
- Support on regulatory submissions and filings.
The Senior QA Design Assurance Specialist will report to the Manager, Development QA.
Qualifications
- Masterβs degree in biomedical engineering or related field of study.
- +8 years of experience in development of Medical Devices/In Vitro Diagnostics (IVD), and/or Pharmaceuticals.
- Experience with primarily hardware, but preferably also software and/or reagents.
- Strong skills within design control and understanding of ISO14971, ISO62366, ISO62304.
- Thoroughly versed in Quality System Standards (ISO13485, FDA CFR21 Part 820, MDSAP) and IVD/Medical Devices legislation in EU and USA.
- Strong analytical skills with focus on finding the right solutions in compliance with applicable regulations and QMS requirements.
- On a personal level, you are process and detail oriented as well as a proactive team player whoβs capable of working cross-functionally with people at all levels of the organization.
- Full fluency in English on business level. Note that fluency in Danish is not required but preferable.
We Offer:
- An inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, sustain and manufacturing activities. Β
- A great opportunity for you to make a significant impact and develop your skills in a world-class company that takes pride in developing new innovative solutions for the pathology labs around the world to improve cancer diagnostics. Β
- A role among passionate colleagues, in a growth orientated and inclusive environment. You will become part of a caring and fast paced environment, built on integrity, sharing and trust.
- Agilent offers core global benefits to all staff - but in addition to these, the DK business offers Agilent Result Bonus, Stock Purchase Plan, Life Insurance, Pension, Healthcare, Physiotherapy and much more.
Additional Details
This job has a full time weekly schedule.Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.