(1/18/2025 A) Quality Systems Specialist

12 hours ago


Galway, Ireland Life Science Recruitment Full time

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

- Provides QA technical and compliance support for products and manufacturing related to suppliers, corrective and preventive actions, product/process improvements and training.
- Applies thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Plans, executes, reports and follows-up on quality system audits (supplier and internal).
- Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations.
- Makes decisions that are aligned with management objectives regarding work processes, plans and schedules to achieve quality objectives.
- Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
- Resolves project issues by working with team members, management, suppliers, and others as appropriate.
- Assists department and project leaders in developing and reporting appropriate performance and quality metrics.
- Reviews and approves manufacturing, test and validation data/records to establish conformance to technical specifications and performance standards for existing, new or modified products and processes.
- Provides technical quality guidance to team members, technician and inspection staff.

Education & Experience

- Bachelor's Degree in Engineering, Science or related technical field preferred.
- QA, Quality System or regulatory experience in the medical device or similar highly regulated manufacturing environment.

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