An Assoc Dir QA Med Device is required for our Limerick based trailblazing pharma client. This role provides QA oversight of the Medical Device/Combination Products including pre-filled syringe and auto-injectors/pen injectors for biological therapeutics developed in-house and in collaboration with partners and CMO's.
Role of this position
- Provide leadership to the Medical Device Quality Oversight team. Implement and maintain the Quality Management System ensuring compliance to all applicable combination product/medical device regulations.
- Provide Quality Assurance oversight for the Combination Product Development function.
- Provide guidance and participate in Design Development, Design Transfer, and Commercialization reviews and activities; and where appropriate in Feasibility, Development, Design Verification, Design Validation activities associated with combination products.
- Function as the primary interface for QA advising on combination products quality issues within the organization. Work effectively and influence multiple functions (Combination Product Development, Operations, Commercial, Regulatory, Supply Chain, etc.) to ensure quality requirements are met
- The preferred candidate will have 5+ years of relevant experience with a Bachelor's degree (Life science / Engineering).
- Proven experience in global applications of Quality Risk Management and Quality Assurance in the medical device field at a multi-site level.
- Device regulation (design control) experience required.
Please call Michael Hanrahan today for further information on 021-2019817 or email: firstname.lastname@example.org
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