( SR ) Quality Engineer

TECHNICUS.NL -  Eindhoven
9 dagen geleden   |   38x bekeken

Functie omschrijving


  • Design Assurance Quality Planning (i.e. new product development, design excellence, and design transfer)
  • Actively participate in the design control process: planning, design input, design output, design review, design verification, design validation, design changes, and design history file maintenance
  • Apply appropriate risk management tools (i.e. FMEA's) throughout all projects and that the tools used are consistent with applicable regulatory standards and industry practices
  • Ability to effectively facilitate design reviews and requirements traceability activities
  • Ensure the design history file is complete accurate and defensible for each product release
  • Product quality planning through the use of quality control plans and product & process FMEA tools
  • Assure regulatory compliance by meeting or exceeding the requirements in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, CMDR, MDD, J-PAL and ISO 14971
  • Give an advice for release for delivery: preparing release documents, issuing Standard Compliance Certificate (compliance to external safety/legal standards)) and put these data into the Agile system
  • Work with the R&D team to measure and improve the design control process
  • Establish a dashboard of metrics, reports and statistical techniques that indicates the level of product quality at any stage of development or manufacturing
  • Conduct quality audits planned in the Product quality plan and in the yearly audit program

Your profile (education and experience)

  • You have a BSc in Engineering or Physical Science with a minimum of 5 years direct related experience in medical device industry
  • Knowledge and understanding of FDA, ISO, and MDD regulations and project management and organizational skills
  • 21 CFR820; SOR 98-282
  • ISO 9001; ISO 13485/14969 ; ISO 14971
  • EN / IEC 60601-1 (2nd and 3rd edition)
  • IEC62304 or GPisSV; Software Validation
  • IEC 62366 (Medical devices - Application of usability engineering to medical devices
  • As a person you have strong interpersonal and influencing skills as well as analytical/Statistical skills
  • Fluent in English
  • You are able to work under pressure to meet regulatory & company requirements and timelines

Professional and behavioral competencies required

  • Adaptability & Flexibility
  • Conflict management/Mediating Disputes
  • Initiative
  • Problem solving
  • Persuasion
  • Effort/Quality
  • Stress Tolerance
  • Listening
  • Results Focus & Initiative
  • Influencing Others
  • Coaching & Mentoring (of peers/project members)

Philips Consumer Lifestyle B.V.

With a growing presence in cardiology, oncology, and women’s health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor’s office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare’s unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.

Philips Personal Health is one of the market-driven sectors within Royal Philips Electronics, delivering lifestyle solutions for personal well-being. The sector builds on a deep understanding of people’s needs and aspirations to create meaningful innovations that help consumers achieve their lifestyle ambitions. The growing Innovation site Eindhoven is part of Innovation & Development (I&D) Personal Health. It focuses on the development of medically and non-medically lifestyle products. It is responsible for the development and realization of new product propositions. The Innovation Site Eindhoven is looking at a very challenging growth task to bring more new ideas to the global market. The group Function Development and Architecture matches the consumer needs to technical solutions. It spans the whole range from first ideas, proof of principles to product implementation and transfer to production.

Department description

  • Responsible for supporting the Design Quality Assurance efforts within the MR Team (i.e. new product design and development, design transfer, design validation, risk management, etc.)
  • The Quality Engineer works closely with R&D regarding product quality planning that will have significant impact on the business
  • The Quality Engineer maintains communication with the Director Design Assurance and the VP of R&D for assistance in resolving major quality initiatives/projects and executing design, development, and design transfer initiatives
  • The Quality Engineer works with various departments and drives CAPA throughout the organization as a CAPA Champion


Vacature contactpersoon TECHNICUS.NL
5656AA Eindhoven

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