Quality Assurance Engineer

Location: Eerbeek, Brummen, Netherlands

Job title: Quality Assurance Engineer
Department: CVI Quality
Location: Eerbeek, Netherlands
Working Hours: Mon-Fri, 40 hours per week (Onsite 5 days per week)

A brighter future awaits you

CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.

Scope:

The Quality Assurance Engineer is responsible for ensuring that products and processes meet all requirements established by global guidelines and regulatory requirements. They will perform quality assurance activities for our Procornea site, based in Eerbeek, Netherlands.

Job Summary:

The QA Engineer provides support to Regulatory Affairs, Operations and Marketing on design controls, risk management, verification and validation practices, and statistical methods assurance to support product and process development and manufacturing of medical devices in an environment that embraces teamwork, change, risk-based decision making and flexibility.

Essential Functions & Accountabilities:

• Support and review process development, including verification/validation, risk management, etc.
• Utilize risk-based approach to assess and control manufacturing changes.
• Provide quality engineering support of medical device products to ensure that quality requirements are translated into product and process functional specifications.
• Support the development of the inspection methodology and acceptance criteria for sampling plans, including the incoming, in-process, final and validation sampling plans.
• Support statistical analysis for sampling plan rationale and analysis, including but not limited to, DOEs, Pareto’s, ANOVA and SPC applications.
• Perform internal and supports external Audits to maintain Quality System Regulation requirements.
• Support company goals and objectives, policies and procedures in compliance with quality manual and quality system processes such as CAPA system, change control.
• Creates a culture of quality awareness, teamwork and cooperation with all groups within the facility.
• Works closely with Manufacturing and other functional groups, to ensure compliance to applicable standards (external and internal) such as ISO 13485 and ISO 14971.
• Examines work for thoroughness, exactness, neatness and conformance to policies and procedures.
• Investigates instances of nonconforming material and facilitates the determination of root cause and corrective action/preventive action. Supports team leads responsible for the improvement activities.
• Participates in supplier approval and evaluation and leads supplier improvement efforts.
• Coordinates calibration and training requirements for the department.
• Document control management.

Experience:

• Consultation and negotiation of different departments concerning Quality related subjects.
• Consultation and negotiation with certified bodies, laboratory, suppliers and other Cooper divisions.
• Excellent knowledge of the Dutch and the English language (written and verbal, work instructions, protocol reports, management review).
• Knowledge of norms and Medical Device related regulations, such as GMP- and ISO 13485 / MDR-standards, risk and change management. 
• Experience with SOP, validation, and technical writing.
• Must have experience with Internal Auditing in a Medical Device field. Audit Training certifications preferred.
• Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma GB or CQE preferred

Education

• Bachelor in an engineering or science discipline or equivalent combination of education and experience.