Quality Engineer

Wat ga je doen?

As a Quality Engineer you are responsible for the quality and reliability of ViCentra medical devices, working on Quality Engineering and Supplier Control, ensuring compliance in operational processes and manufacturing output which consistently conforms to ViCentra’s regulatory and quality specifications. You will report to the Senior Quality Control Manager and work in a team with four other Quality Engineers and one Teamlead for the QC Inspectors.

Key responsibilities

• Write/revise/review procedures, specifications and work instructions to ensure component consistency and fulfilment of product performance needs and develop/validate inspection -, manufacturing - and Quality processes, test methodology, quality plans.
• Ensure documentation is up to the required standard, delivered on time and within required specification, raising, support/ lead investigation and RCA of CAPA’s and NCR’s when required.
• Conduct on-site calibrations and/ or support external calibrations.
• Provide Quality training to the organization.
• Develop, apply and maintain supplier (internal and external) quality requirements and standards for the manufacture of ViCentra product components.
• DHR review of final product / CMO product and release
• Collaborate with Suppliers to promptly identify and resolve Quality issues by root cause investigation, ensuring compliance to ViCentra’s standards.

Wat vragen wij?

• You have a degree in Mechanical Manufacturing Engineering, Biomedical Engineering or a related technical field.
• You have a comprehensive understanding of worldwide medical device quality regulations (ISO 13485, MDD/EEC 93/42, MDR and 21 CFR 820), Good Manufacturing Practices (GMP) and applicable Quality System Standards
• You’re analytical, have excellent reporting skills and have experience writing technical documentation.
• You’re solution focused with a high level of self-motivation, drive and tenacity.
• You’re able to communicate effectively on different levels in the organisation and are team-orientated.
• Experience with a Cleanroom environment, Minitab, Measurement Systems (Micro-Vu Vertex) or/and as a trainer – that’s a big plus.

Don’t meet every requirement? We value potential and encourage you to apply!

Wat bieden wij?

• Meaningful work, autonomy and a salary matching your level of experience.
• 25 days of holiday per year and the opportunity to take the Dutch national holidays on any day that suits you
• Participation in the company pension scheme
• Subsidised gym membership, phone allowance, a tax friendly bike scheme and budget to facilitate a home office set-up
• A diverse and inclusive work environment including a team of 45+ different nationalities.