Quality Assurance Engineer
As a Quality Assurance (QA) Engineer, working within the CooperVision Specialty EyeCare Division at Procornea, you will be responsible for providing support and reviewing process development, including verification/validation and risk management. Ensuring that products and processes meet all requirements established by global guidelines and regulatory authorities. You will perform quality assurance activities for Procornea B.V. You will provide 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.
Besides, you use Quality Engineering principles – Problem Solving and Root Cause Analysis tools-techniques to develop and optimize systems and processes so that they are aligned with the overall Company strategy. You will lead and assist in process and product improvement projects. Technical input and assistance will be provided by you while adhering to regulatory requirements.
Essential Functions & Accountabilities:
- Applying a risk-based approach to assess and manage production adjustments.
- Supporting implementation of medical devices requirements to ensure that quality requirements are translated into product and process specifications.
- Assisting in the development of inspection methods and acceptance criteria for sampling plans.
- Performing statistical analysis for sampling planning and analysis, including DOE's, Pareto analyses, ANOVA, and SPC applications.
- Conducting internal and external audits to comply with quality system requirements.
- Supporting corporate objectives, policies, and procedures in accordance with the quality manual and quality system processes.
- Creating a culture of quality awareness, teamwork, and collaboration within the organization.
- Collaborating with production and other functional groups to comply with applicable standards such as ISO 13485 and ISO 14971.
- Investigating cases of non-conforming material and determining root cause and corrective/preventive actions.
- Participating in supplier approval and evaluation and leading supplier improvement efforts.
- Coordinating calibration and training requirements for the department.
Knowledge, Skills and Abilities:
- Bachelor's degree in a technical or scientific discipline or equivalent education and experience.
- Excellent knowledge of both Dutch and English languages (written and spoken).
- Knowledge of standards and regulations related to medical devices, such as GMP and ISO 13485/MDR.
- Experience with SOPs, validation, and technical writing.
- Experience with internal audits in the medical device industry is required; audit certifications are a plus.
- Applied technical knowledge of qualitative and quantitative data analysis and statistical tools; Six Sigma GB or CQE is a plus.
- Structured, Analytical, Detail oriented, Communicative, Independent, Teamplayer, Proactive, Solutions oriented, Pragmatic
What we offer:
You will join a modern, growing and informal company at the forefront of Contact Lens development, we have 30 days of leave and a good pension plan, among other things. You will have a varied job with many interesting challenges, no two days are the same. In addition, we find it important that you can continue to develop yourself.
Are you enthusiastic about this role? Email your resume and motivation to [email protected]. For further information you can contact Colinda van den Broek, RAQA Manager or Susan Duteweert, HR Administrator: 0313-677677.