We are on the lookout for a Quality Engineer to strengthen the Quality Assurance team and ensure that the company quality standards and customer expectations are met. Besides meeting these expectation you will also be pivotal in the continuous improvement of the QMS system and the organization.

You will be part of a team of 4 QA co-workers and report to the Quality Manager.

As Quality Engineer you will be responsible for:

• Ensure active and thorough investigation related to Complaint handling, ensure timely closure of the Complaint cases.
• Review and approve Validation and IOPQ reports.
• Review and approve Quality documents.
• Assist in the preparation and execution of external audits from Regulatory Bodies and customers.
• Track, analyze, and report Quality metrics to identify trends and drive continuous improvement.
• Ensure active and thorough investigation of Quality issues, identifying root causes, identifies Manufacturing process defects and implementing Corrective Actions.
• Review and approve CAPAs (Corrective and Preventive Actions), NCRs (Non-Conformance Reports), and Planned/Unplanned deviations within a timely manner.

The successful candidate will meet the following criteria:

• Requires Bachelor level education in Science or Engineering related field.
• Minimum 5 years’ experience in Quality Assurance in an ISO 9001 and/or GMP related industry.
• Good oral and written communication and presentation skills (Dutch and English).
• Must be resourceful and self-motivated.
• Focus and attention to detail is critical.

Preferred :

• Experience with ISO17025, ISO13485 or equivalent standards.

Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, fast-paced environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Breda, Netherlands.