The Quality Engineer is responsible for ensuring the quality, compliance, and continuous improvement of medical device products and processes throughout the product lifecycle. The role provides quality support across Supplier Management, Incoming Inspection, Manufacturing, Product Release, New Product Introduction, Validation, Complaint Handling, Non-conformance, CAPA management, Auditing, and Quality Systems Activities. Working cross-functionally, the Quality Engineer helps maintain compliance with regulatory and quality requirements while driving operational excellence and product quality.
The associate in this role has the authority and responsibility to:
GENERAL AUTHORITY:
· Stop or escalate activities that may adversely affect product quality or regulatory compliance.
· Escalate quality concerns to management when timely resolution is not achieved.
· Recommend improvements to quality systems, procedures, and processes.
· Request investigations and corrective actions for identified quality issues.
· Participate in quality-related decision-making within the scope of the role.
· Access quality records and data necessary to perform assigned responsibilities.
· Support the approval process for quality documentation within delegated authority limits.
GENERAL RESPONSIBILITY:
· Perform duties in compliance with the company Quality Management System (QMS), applicable regulatory requirements, and company policies.
· Promote a culture of quality, compliance, and continuous improvement throughout the organization.
· Support the achievement of departmental and company objectives.
· Collaborate effectively with cross-functional teams including Operations, Supply Chain, Regulatory Affairs, and Engineering.
· Maintain accurate, complete, and timely quality records and documentation.
· Participate in training activities and maintain competency in assigned responsibilities.
· Identify quality risks and escalate issues appropriately.
· Support internal, external, customer, and regulatory audits as required.
· Contribute to process improvement initiatives that enhance product quality, compliance, and operational efficiency.
· Ensure confidentiality of company, supplier, and customer information.
· Support a safe working environment and comply with all Environmental, Health, and Safety requirements.
· Act as a quality representative in cross-functional projects and meetings as required.
Qualifications:
· Bachelor’s degree in a relevant field (e.g. engineering, life sciences, quality management etc.)
· Knowledge of ISO13485, EU MDR, FDA QMSR and applicable medical device requirements.
· Certification in ISO13485 auditing is an advantage.
· Familiarity with ERP and MRP systems.
· Knowledge of risk management principles (ISO14971)
Skills
· Excellent understanding of Quality management principles.
· Ability to interpret and apply regulatory requirements.
· Ability to train and mentor staff on ISO13485 standards.
· Strong decision making and problem-solving skills.
· Proficiency in using QMS tools.
· Strong attention to detail and organizational skills.
· Strong organizational skills.
· Continuous improvement mindset.
· Effective communication.
· Team collaboration.
· Ability to work independently.
Experience
· Minimum of 2 years of experience within the medical device industry in a similar role.
Proven track record of successful regulatory audits.
Pay: €60,000.00-€63,000.00 per year
Benefits:
- Bike to work scheme
- Company pension
- Employee assistance program
- On-site parking
- Private medical insurance
Work Location: In person
