Philips Quality assurance officer iXR in Best, Netherlands
To provide Quality Assurance support and oversight to ensure compliance with Quality System and regulations that govern product development activities within the Interventional X-Ray (IXR) department.
· Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining way of working
· Support New Product Introduction by providing QA technical expertise, assessments, and strategies for problem resolution & prevention
· Serve as Subject Matter Expert for quality system and design control requirements within project teams
· Participate in risk assessments and take appropriate action during QA oversight activities to ensure adequate controls in relation to level of product quality, safety and business risks.
· Review and approve Product Design Quality Records (DHF documents such as specifications, risk assessment reports, validation & verification test protocols/results/reports, etc.)
· Review and approve Corrective Actions and Preventive Actions (CAPA) in order to meet compliance requirements.
· Review and approve product change controls for quality and regulatory compliance impact and determine requirements for implementation
· Accountable for interactions to enhance QA reputation within the company and to promote teamwork & understanding of quality requirements.
You will be a member of a 12FTE Quality Officers team.
We are looking for
· MS in related field plus 2+ years of QA experience, BS/BA in technical field with plus 4+ years’ experience.
· Demonstrated knowledge & expertise on subjects mentioned below but not limited to:
o ISO Standards (i.e., 13485, 14971, 14001)
o US, EU & International Medical Device Regulations (i.e., 21 CFR 820, MDD)
o Medical Device Design Control Requirements
· Lead Auditor Training
· Excellent Communication
· Excellent QA/Regulatory Writing Skills in English
· Proficient in Microsoft and other organizational tools
· Ability to effectively interact with various business departments & resolve QA compliance/technical issues/conflicts
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
· A market conform salary
· 25 Days of leave and the possibility to purchase up to 20 extra days off annually
· A variable bonus based on both Philips results and personal performance
· Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
· Solid company pension scheme (employee contribution fee 0%), and attractive collective health insurance package Opportunity to buy Philips shares and products with discount
· Healthy work-life balance
Best, the Netherlands.