Systems Design Quality Engineer

JOB DESCRIPTION

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

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.

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