Quality Systems Specialist

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.

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