Experienced Sr. QA Product Quality Specialist (m/f/d)

Your Profile:

• 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.

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.

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