Morgan McKinley is recruiting a Quality Assurance Specialist for our client, a leading company in the medical device sector. This company is based in Cork and is a 12 month contract. As QA Specialist you will be responsible for ensuring that all products meet exact standards for quality, safety, and regulatory compliance. As a vital member of the quality team, you will manage and enhance the company's Quality Management System. Your duties will also include supporting products throughout their lifecycle, overseeing the final batch release, and guaranteeing compliance with all relevant industry and government regulations.
Key Responsibilities
- Support the implementation and ongoing maintenance of the Quality Management System.
- Review and approve batch documentation to ensure compliance with applicable regulatory requirements and quality standards prior to batch release.
- Collaborate with cross-functional teams to maintain GMP and regulatory compliance across operations.
- Review, manage, and maintain Device Master Records, Device History Records and other related quality documentation.
- Participate in investigations and resolution activities related to quality issues, non-conformances, and customer complaints.
- Assist in the development, implementation, and monitoring of Corrective and Preventive Action
- Support internal and external audits, including preparation, execution, response coordination, and follow-up actions.
- Work with cross-functional teams to ensure quality standards are upheld throughout all stages of the product lifecycle.
- Provide Quality Assurance oversight for manufacturing, packaging, labeling, and distribution processes.
- Contribute to the creation, review, and maintenance of Standard Operating Procedures, work instructions, and other controlled documents.
- Maintain quality records and ensure adherence to proper documentation practices.
Qualifications & Experience
- Bachelor's or Masters degree in Engineering, Science or related discipline.
- Minimum of 3+ years experience in Quality Assurance roles within the medical device or other regulated sectors
- Quality Management Systems for Medical Devices such as GMP/GDP, ISO and FDA
- Proven experience leading investigations, managing CAPAs, and participating in audits.
- Strong technical writing and communication.
- Excellent analytical and problem-solving abilities.
- High attention to detail.
- Ability to work effectively in cross-functional teams.
