Senior Supplier Quality Engineer

Wat ga je doen?

We are seeking a senior supplier quality engineer to join our vibrant medical device scale-up. In this position you are responsible for the quality and reliability of ViCentra medical devices, working on Supplier Control and Quality Engineering, ensuring compliance in operational processes and manufacturing output which consistently conforms to ViCentra’s regulatory and quality specifications.

Main Responsibilities include but are not limited to:

• Collaborate with Suppliers to promptly identify and resolve Quality issues by root cause investigation, ensuring compliance to ViCentra’s standards.
• Implement corrective and preventive actions to drive continuous improvement in Supplier performance. Perform effectiveness monitoring.
• Collaborate with engineering, procurement and manufacturing to collectively address quality concerns. Develop, apply and maintain supplier (internal and external) quality requirements and standards for the manufacture of ViCentra product components.
• Analyse and monitor Supplier data on defect rates, delivery times and quality adherence to optimise performance. Analyse internal Supplier control process performance, setting performance metrics.
• Evaluate technical supplier quality assurance and control/reliability systems and standards pertaining to materials, machines, processes and components.
• Provide regular progress reports (Quality Data Metric) to ViCentra Management and key stakeholders, highlighting current issues, quality risks and possible strategies for managing and mitigating those risks.
• Play a leading role in the process of Supplier selection and evaluation to ensure compliance to ViCentra’s standards.
• Support/carry out Supplier audits. Support internal/external audit when required.
• Write/revise/review procedures, work instructions and specifications. Ensure documentation is up to the required standard, delivered on time and within required specification.
• Raise, support/ lead investigation and RCA of CAPA’s and NCR’s when required.
• Identify quality process bottlenecks and suggest actions for improvement.
• DHR review of final product / CMO product and release.
• Support of manufacturing from a Quality point of view. Participating in daily stand-up meetings.
• Participates in risk management sessions.
• Promote strong cooperation between both in-house manufacturing team and external suppliers, fostering accountability, a culture of operational excellence and a quality mindset.
• Accomplish goals by accepting ownership; exploring opportunities to add value to job accomplishments.
• Ensure work is undertaken within defined timescales.
• All work to be undertaken and completed with a high level of accuracy and attention to detail.
• Working independently with minimal supervision as well as ability to work closely with other departments.
• Ensure compliance with all regulatory, legal and Company policies and procedures.
• Provide Quality training to the organization.

Wat vragen wij?

 Education/Experience:

• Degree in Mechanical Manufacturing Engineering / Biomedical Engineering/ related technical field or equivalent industry experience
• A comprehensive understanding ISO 13485, MDD/EEC 93/42, MDR and 21 CFR 820
• Good Manufacturing Practices (GMP) and applicable Quality System Standards
• Analytical and reporting skills
• Fluent written and spoken English
• Solution focused with a high level drive and tenacity
• A drivers license valid in The Netherlands
• Able to communicate effectively with good listening skills

Desired:

• Minitab experience
• Experience with Video Measurement Systems (Micro-Vu Vertex)
• Experienced in writing technical documentation
• Experience with Cleanroom environment
• Experience as a trainer

Wat bieden wij?

In addition to working on a ground-breaking new product, you’ll be working in a small, friendly and highly motivated team; all ideas are welcomed, and great work is rewarded. We’re also offering:

• Meaningful work with the opportunity to make a difference
• Up to 46 days leave per year (25 days’ holiday per year + up to 13 ADV days per year + 8 optional unpaid leave days)
• Defined benefit pension
• Flexi-working, where full time its 40 hours per week, 8 hours per day to be worked anytime between 07:00 to 19:00 Monday to Friday
• Commuting allowance
• Laptop + mobile phone allowance
• Competitive relocation package and assistance if needed
• Assistance for 30% ruling application if applicable
• Free, on-site parking
• Subsidised gym membership
• Bike Scheme
• Informal dress code
• A work environment where you can develop your skills, learn from the best and be rewarded for your imagination
• Creative office vibe with a picnic area and ping pong table