Our client is seeking to recruit Quality Manager to join their team in Mayo
Plan and maintain quality assurance systems to ensure process and test reliability and conformance, Customer and Regulatory requirements. As a member of the site Management team, contribute to performance of the Company and provide inputs and suggestions on normal routine business matters for Quality Assurance and Technical matters
The Site Quality Manager has specific and general responsibilities in respect to the Quality System.
- The Designate Management Representative with the authority and responsibility to ensure the documented Quality System is implemented
- Audits, generate reports and quality plans and verifies that the necessary corrective actions are taken to ensure ongoing compliance with the Quality Manual.
- Initiate action to prevent the occurrence of a process non-conformity.
- Identify and record any process quality problems.
- Initiate, recommend or provide solutions to quality problems through designated channels.
- Verify the implementation of solutions.
- Control further processing, delivery or release of Customer product pending completion of corrective action on nonconforming product.
- Responsible for ensuring appropriate systems for release of client product post processing.
- Analyses Customer complaints and implements corrective actions for valid complaints.
- Responsible for Document Control function.
- Responsible for facilitating Customer and Regulatory audits including generation of corrective actions and ensuring responses to the relevant third party. Ensuring the promotion of awareness of regulatory and Customer requirements throughout the organisation.
- Responsible for ensuring process commissioning, validation and any subsequent re-validation deemed necessary as a result facility engineering changes or Customer product/requirements changes are documented, approved and implemented.
- Provides technical assistance and support to Customers in the development of validation protocols subsequent validation reports, and routine processing problems.
- Responsible for ensuring process, test and raw materials specifications remain current, by conduction internal audits; ensures that these specifications are met.
- Life Science/Engineering qualification and 3-5 years a relevant industrial experience with Quality systems.
- Requires comprehensive knowledge and hands-on experience of quality standards and procedures; ideally in the area of sterilisation and validation.
- Working knowledge and experience of medical device manufacturing, related GMP and an appreciation of FDA compliance inspections.
- Ability to work well with people and act as a facilitator to staff not directly reporting to this position is important.
- Ability to communicate with clients is essential.
If you would like to apply for this position you can call Aileen on 0949029944 or you can forward your CV to email@example.com