QA manager - Medical Devices - R&D - Tilburg

Tilburg, Netherlands
14 Nov 2016
14 Dec 2016
Ly Kien
Contract Type
Full Time

Progressive looking for an experienced QA specialist in Medical Devices R&D departments. The company is based in the area of Tilburg and the project duration is about 4 months. Are you a talented quality professional looking for a temporary challenge in a healthcare environment? Please continue reading!

For this function, you have to maintain and assure the quality and safety of products, which can be medial and non-medical. Risk management, design quality assurance activities and coordination of these activities together with other departments are your key challenges.

What are your responsibilities?

  • Accountable for Quality Management System
  • Support Q&R compliance to assure products comply with QMS requirements
  • Support, instruct and coach project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
  • Review requirements management process to 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

What are the job requirements?

  • You have either a bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.
  • Strong knowledge of global medical device or consumer product regulations, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
  • You have experience in a medical device industry.
  • Strong communication skills: across teams and programs, from senior to administrative personnel. You have experience leading remote teams.
  • You are detail oriented and able to see big picture

Are you available and interested in the role? Give me a call on +31 10 206 9888 or leave me a message! Should you know someone suitable for this function, do not hesitate to share with me!