Position: Quality Assurance Manager
To assure the Quality and Safety of Innovative (Medical and Non-Medical) products in a Dynamic Environment.
Key challenges include risk management, design quality assurance activities and co-ordination of quality activities with Engineering, procurement, manufacturing, clinical, service and support teams. Supports organization to work compliant in a lean way.
• Instruct, coach and facilitate project team’s w.r.t Innovation Site Eindhoven-Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.).
• Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
• Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements
• Create quality function deliverables as per Innovation Site Eindhoven –Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
• Review Requirements Management process and outcome.
• Reviews Product Verification and Validation.
• Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
• Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility.
• Ensures timely execution and required communications and escalation.
You will be part of the Q&R team consisting of approximately 30 team members working for the businesses- Mother &Child Care, Skin Care, Connected Health Devices & Pain Relief reporting to the QAM Group lead. You will be based in Eindhoven, The Netherlands. You will work in project teams with co-ordination with marketing teams, manufacturing teams at various sites, supplier teams, and other Q&R members across Philips.
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
We are looking for
• Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.
• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
• Preferably experience in a medical device industry.
• Proven ability to successfully incorporate and manage stakeholder needs throughout a project
• Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams.
• Both detail oriented and able to see big picture
I am explicitly looking for
- Development Quality experience, where one
o has worked with R&D (product development)
o can drive the product quality
o Risk management
o Ensure the product/consumer safety aspects
o Well versed with ISO13485 / IEC60601 / ISO 14971
And not with just
- QMS (Quality Management System experience)
- Supplier Quality
- Process Quality (APQP or IQ/OQ/PQ)