Key Responsibilities will include
· Manages quality systems within the plant which are necessary to meet manufacturing and regulatory requirements
· Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
· Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
· Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
· Ensures the quality assurance programs and policies are maintained and modified regularly.
· Act as Subject Matter Expert (SME) for the site in the areas of validation, calibration, and manufacturing quality engineering support.
· Use quality engineering methods/techniques to ensure products released for distribution meet their intended performance requirements for safety and efficacy.
· Participate and provide technical support on technical project teams.
· Support manufacturing transfer from R&D.
· Support inter site technology transfer.
· Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
· Work with Design QA with respect to compilation of risk assessments where applicable.
· Provision of trending and associated metrics for the areas of calibration, validation, and manufacturing support.
The successful candidate will have
· A third level qualification (Level 8) in quality or a related discipline.
· A good understanding ISO 13485, FDA QSRs, JPAL and Canadian Medical Device regulations is desirable for this position in tandem with strong analytical, technical writing and computer literacy skills
· Five or more years’ experience in a quality role encompassing the areas listed above
· Familiarity with global regulatory standards associated with medical devices
· Excellent oral and written communication skills
· Lead auditor qualification preferred, not required.
For more information please contact Clodagh D’Arcy on 01 9476356/087 3470221 or email details to Clodagh.email@example.com