Job Title: Senior Quality Assurance Engineer
Based in Oranmore, Galway.
Benefits:
* Excellent salary
* Income Protection
* Life Assurance
* Contribution of €2,000 per annum in lieu of health insurance
* Pension Scheme
* Annual discretionary bonus up to 10%
* Educational Assistance
* Employee Referral Programme
* Cycle to Work Scheme
* Sports & Social Activities
Role:
As a Senior Quality Engineer, you will be responsible for implementing and promoting best-in-class quality assurance through the product lifecycle for our client device.
Company Overview:
We are a leading provider of medical devices for chronic rhinitis patients. The role requires a minimum of 5 years' experience in quality management systems within the medical device industry.
Responsibilities:
Key Accountabilities:
1. Ensure compliance with quality systems procedures.
2. Lead and coordinate the internal audit program.
3. Manage interactions with regulatory bodies, including FDA and certification bodies.
4. Act as audit lead for any inspections/audits.
5. Collect and analyze quality system data for reporting across the organization.
6. Manage the complaint handling and corrective action process.
Requirements:
Essential Qualifications:
* Degree in Quality Assurance, Quality Engineering or similar qualification.
Desirable Experience:
* Minimum 5 years' experience in a relevant role in the medical device industry.
* Broad experience of Medical Device Quality Management Systems, including electronic QMS systems.
* Experience in CAPA system management and Complaint handling systems.
* Familiarity with ISO13485 and 21CFR Part 820 FDA requirements.