Systems Design Quality Engineer

Job Title

Systems Design Quality Engineer

Job Description

The Systems Design Quality Engineer assures the quality, reliability, effectiveness and safety of innovative (medical and non-medical) products in a dynamic environment. Key challenges include risk management, design quality assurance activities, compliance with standards and regulations, resolving quality issues, driving continuous improvement and co-ordination of quality activities with engineering, procurement, manufacturing, clinical, service and support teams. Supports organization to work compliant in a lean way.

Your responsibilities 

• Instruct, coach and facilitate project team’s w.r.t 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.

Your team

You will be part of the Q&R team consisting of approximately 30 team members working for the business unit Grooming & Beauty reporting to the Quality Group Lead. You will be based in Drachten, 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 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

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week on our Philips Drachten site.