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Senior Quality Engineer

1 month ago

Galway, Galway, Ireland Life Science Recruitment Full time
Job title: Senior Quality Assurance Engineer
Location: 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 my client device.

Company:
My client has developed a product on the market which is an effective option for both long-term and newly diagnosed chronic rhinitis patients. The role requires a minimum of 5 years quality management systems experience in the medical device industry, and the candidate must exhibit excellent problem solving and an innovative rational mindset to ensure implementation of advanced, efficient appropriate quality management practices.

Responsibilities:

1. Responsible for compliance with quality systems procedures. Is viewed as the leader in areas of quality systems ISO13485 standards and 21CFR Part 820 compliance.
2. Champions continuous improvement and innovation in the quality system, developing and improving procedures and systems for efficient compliance.
3. Lead and coordinate the internal audit program and ensure that Internal Audits are completed to schedule.
4. Lead interactions with FDA and with certification bodies in relation to QMS auditing, certification, and changes. 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 and preventive action process.

Experience required:

1. Degree in Quality Assurance, Quality Engineering or similar qualification.
2. Minimum 5 years' experience in a relevant role in the medical device industry.
3. Broad experience of Medical Device Quality Management Systems, including electronic QMS systems.
4. Experience in CAPA system management.
5. Experience in Complaint handling systems.
6. Experienced in ISO13485 and 21CFR Part 820 FDA requirements and managing regulatory body audits.

Does this sound like your next career move? To apply and for more info, forward your application to the link provided or contact me on 087 0612325 or thomas.gallagher@lifescience.ie
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