QA Design Assurance Specialist
1 month ago
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 QA Design Assurance Specialist to represent QA in design control activities for our reagents, instruments and software.
The QA Design Assurance Specialist will be responsible for ensuring compliance with internal and external requirements during design and development of new products, especially with regards to design control, including e.g. requirements, risk management, V&V activities and change control.
The 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, Production and Marketing. The focus will be to:
- Provide guidance on design control activities to identify innovative and efficient solutions for various 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.
- 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.
Qualifications- 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 the right solutions in compliance with the regulations.
- Excellent communication and collaboration skills.
- Ability to make independent decisions/complete tasks within the 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.
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 orientated and inclusive environment. You will become part of a caring and fast paced environment, built on integrity, sharing and trust.
- 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.
- 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.
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: Agilent Careers . Agilent 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.
Travel Required:No
Shift:Day
Duration:No End Date
Job Function:Quality/Regulatory
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QA Design Assurance Specialist
1 month ago
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