Experienced Sr. QA Product Quality Specialist

Job Description
Are you experienced within design control and post market activities of medical devices and interested in making a difference in cancer diagnostics worldwide?

We are looking for an experienced Sr. Product Quality Specialist within Product investigations; CAPA´s, complaint analysis and design control activities for our many launched reagents.

In the role, you will be responsible for ensuring compliance to Agilent’s QMS and external requirements, especially with regards to the Product Evaluations/Investigations, QA product support, Design Control/ Change Control, including but not limited to Risk Management and V&V activities.

You will also be responsible for driving initiatives to ensure continuous improvements of our processes within the product quality area as well as collaborating with international colleagues to achieve company goals.

You will have a close collaboration with R&D, RA, Marketing, Complaint Center, Field Action and Post Market department to assure high quality of documentation in all lifecycle phases of our Reagents.

You will report to the Department Manager for QA Product Quality.

To be successful in the role you must have excellent communication and collaboration skills and take pride in working with project teams to deliver high quality products and documentation at scheduled time.

Qualifications

• Academic degree in Engineering, Biochemistry or related field of study.
• +10 years of working with QA/design control, risk management, post market activities and sustain activities of IVD or Medical Devices.
• Experience working with ISO 13485, FDA CFR 21 Part 820 and ISO 14971.
• Strong analytical skills with focus on finding the right solutions in compliance with applicable regulations.
• On a personal level, you are process and detail oriented as well as a proactive team player who’s capable of working cross-functionally with people at all levels of the organization.
• Full fluency in English. Note that fluency in Danish is not required but preferable.

We Offer:

• An inspiring and social environment with 13 skilled colleagues in the QA Product Quality department providing QA support to both Instrument development and sustain activities and Reagent sustain activities.
• 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.
• 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.

We will ensure you get all the training and development you need to become the best in your field!

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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
Occasional

Schedule
Schedule:Full time

Shift
Day

Duration
No End Date

Job Function
Quality/Regulatory
Location: Denmark-Glostrup