Description

CooperVision is seeking a skilled and motivated Quality Assurance Manager to lead the quality function at our Procornea site in this key leadership role you will ensure compliance with international quality standards and medical device regulations while driving continuous improvement across the organization. You will serve as the sites Management Representative and play a strategic role in both operational and regulatory quality initiatives.

Procornea Nederland B.V. part of CooperVision since 2017 is a high-tech manufacturing site specializing in the development and production of advanced custom-made contact lenses. These include orthokeratology lenses (worn overnight to correct vision) and lenses for myopia management. Our innovative products are manufactured with precision and care supporting eye care professionals and patients across Europe and beyond.

As QA Manager you will directly manage a team of five quality professionals providing leadership coaching and development to ensure a high-performing and engaged team.

Responsibilities

Lead and maintain the Quality Management System (QMS) in compliance with ISO 13485 ISO standards and EU MDR 2017/745.
Act as the sites Management Representative for audits and inspections.
Oversee internal audits document control final inspections and quality control coordination.
Investigate and resolve customer complaints implementing corrective and preventive actions.
Collaborate with Regulatory Affairs to prepare for regulatory inspections and notified body audits.
Approve validation protocols for manufacturing equipment and processes.
Evaluate and approve quality-related vendors; monitor supplier performance.
Develop and manage departmental budgets and forecasts.
Supervise and coach a team of five QA professionals including hiring training performance reviews and career development.
Report on quality system performance to senior management and contribute to strategic planning.

Qualifications

Education & Experience:

Bachelors degree in Chemical Engineering Biochemistry Biotechnology or Materials Science.
Minimum of 5 years of experience in quality management within the medical device industry.
Strong working knowledge of ISO 13485 and its application in a manufacturing environment.
Internal auditor certification is preferred.
Experience with contact lenses or ophthalmic products is a strong plus.

Skills & Competencies:

Proven leadership and people management skills.
Strong communication skills in English (written and verbal).
Ability to manage multiple priorities in a dynamic environment.
Strong analytical and problem-solving abilities.
Proficiency in Microsoft Office (Word Excel PowerPoint Outlook Visio Project).
Ability to work effectively across cultures and languages.

Benefits

Salary Range: annually (full-time including vacation pay).
Bonus: Participation in the MIP scheme (10% annual bonus).
Travel Expenses: Reimbursement of 0.21 per kilometer for commuting distances over 10 km.
Pension: Participation in our pension scheme with 50/50 employer and employee contributions.
Laptop & Phone: All necessary tools provided to perform your role effectively.
Work Expense Scheme: Access to our work-related expense reimbursement program.
Employee Association: Opportunity to join our active employee association for social and professional engagement.
Professional Development: Training and growth opportunities within a global organization.
Flexible Work Environment: Up to 10% domestic/international travel.

Required Experience:

Manager