Our client a leading medical device company in Cork, requires a leader for a Quality Operations team and to provide direction in quality assurance within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes.
- Leads Quality Engineering Team to provide support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality.
- Supports and aligns with the site commitment to ensure the organisation's conformance to producing products meets or exceeds customer requirements and the relevant regulatory standards.
- Fosters a positive employee relations environment by promoting open communication, engagement and development of team members.
- Create a highly talented team by sourcing, hiring, and placing individuals in positions that play to their strengths and future potential
- Drive an environment of compliance by working with all function managers and their support staff to define expected quality standards and the roles/responsibilities in the maintenance of these standards.
- Participates in ensuring the site(s) maintains continued certification to all regulatory bodies. Plays a lead role in all internal and external audit programmes such as Corporate, notified body & FDA audits.
- Ensures effective control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Assesses product & patient risk.
- Supports the planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management
- Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators, and takes timely action to address adverse trends and deviations. Continuously monitors and partakes in global forums to assess opportunities for improvement.
- Assist in developing and supports local and global strategies for the Quality Operations function.
Education, experience and skills:
- Level 8 Degree in Engineering, Science discipline or equivalent.
- Minimum of 6 years' experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
- Experience of successfully creating and managing a talented, engaged and performing team is advantageous.
- Ability to implement organisation and functional strategy. Ability to initiate and implement change with a demonstrated track record (at individual level or team level)
- Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other bodies.
- Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools
For further information on this Manufacturing Engineer role in Galway please contact Cliona O'Malley on 091730022 / email@example.com
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