Quality Assurance Manager
- Sector: High Tech
- Location: Eindhoven
- Industry: High Tech
- Hours per week: 40
- Areas of expertise: -
- Education level: -
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.
About the job
• 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.
• 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
Working at Forexx
You will be employed by Forexx and will have the opportunity to work on long- or short-term assignments. At Forexx we take our full responsibility when it comes to being a good employer and we stimulate the sustainable employability of our professionals. We call this Future Employability. We work with short communication lines within our enthusiastic team. Above all we have a clear and personal communication with our professionals.
We encourage our professionals to keep their knowledge and skills up-to-date through coaching and providing courses / educations where needed. In this way, the skills of our professionals always match the (future) wishes of our customers and we ensure that our professionals can work until their retirement. This is also Future Employability
Excellent secondary employment conditions such as a pension, a discount on your health insurance and travel compensation;
Possibility to follow courses / educations provided by Forexx
Coaching on hard and soft skills;
An interesting network of technical professionals in the field of Manufacturing, High Tech, Networking and Marine & Offshore on a regular basis, with informative meetings and social events.
Question? Contact us
Please reach out to Anouk van Kollenburg (firstname.lastname@example.org) or Irene Naus (email@example.com).