Senior Quality Engineer - Utrecht

Vacancy information

Publication date:May 03 2021
Employment type: Permanent
Sector: Medical Devices
Function Group: Quality/RA

Function Group: Quality/RA / QC Engineer

Organization

For a rapidly growing Medical Devices scale-up, we are looking for a Senior Quality Engineer. The organisation develops and produces innovative and life changing electronic medical devices with the goal to give people more time to enjoy life. This organisation is one that people can rely on.

Currently, the organisation experiences tremendous growth and is expected to become a global leader in the near future. At the moment, about 100 employees work at the organisation. These are talented and ambitious professionals who believe in a work hard/play hard approach.

Function

As a Senior Quality Engineer, your main responsibility will be monitoring and improving the quality of the operational processes and the outputs. You will do this in collaboration with several stakeholders. Together you will ensure all products and processes meet the established quality standards. Furthermore, main responsibilities will relate to:

  • Development and implementation of internal quality standards and quality control systems, in collaboration with QA, RA & R&D
  • Identifying bottlenecks and continuously improving quality systems and processes
  • Monitoring/analysing quality performance and quality control strategies
  • Improve product quality for better customer satisfaction
  • Write, review and approve documents (quality) related to manufacturing, QC and validation
  • Review specifications for component consistency and product performance
  • Develop inspection processes, test methods and quality plans
  • Together with other departments, supporting and guiding validations and related tests
  • Leading/participating in risk management
  • Being involved with internal/external calibrations
  • On-time documentation delivery which is up to standard
  • Raising CAPA’s and Non Conformances (NCR’s)
  • Support/execute root cause analysis
  • Support internal/external audits
  • Develop/give quality training internally

Requirements

A large dose of proactivity and hands-on approach is a must for this role. In addition:

  • Bachelor’s degree in mechanical, quality, biomedical, health science or equivalent
  • 5+ years of experience in Quality
  • Strong track record in Quality Control and therefore skilled in: validation, test method validation and statistical techniques
  • Strong knowledge of ISO13485, 21 CFR 820, MDD/MDR
  • Analytical skills
  • Drive for quality and results
  • Customer safety mindset
  • Continuously improving

Offer

Besides working for a rapidly growing organisation, the company offers you:

  • Expected gross salary range of €55,000 to €75,000 depending on experience
  • 25 holidays and up to 13 ADV (time for time) days per year
  • Defined benefit pension scheme and disability insurance
  • 40 hours per week to be worked anytime between 07:00 to 19:00
  • Assistance for the 30% tax ruling
  • Social events
  • Great and relaxing atmosphere in the office
  • Informal dress code

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Saskia Cepella
Senior Associate Quality & Clinical | Medical Devices

+31 6 13 14 39 73
+31 23 754 86 60
s.cepella@qtcrecruitment.com

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