Job Summary
This is an exciting opportunity to join a leading multinational medical device organization based in Limerick. We are seeking a highly skilled and experienced professional to manage business unit non-conformance, CAPA, complaints, and validations.
Duties:
* Investigate and resolve non-conformances and complaints, trending of same, and assessing need for CAPA.
* Manage on hold product and material (including supplier related holds) up to and including escalation to MRB.
* Support internal and external audits, act as Business Unit Subject Matter Expert.
* Support quality improvement initiatives such as process and product characterizations that lead to continuous and cost improvements.
* Review and analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques, and other improvement tools and programs.
* Review and analyze whether current product and processes are in compliance with standards such as QSRs, ISO 13485, etc.
* Champion compliance to applicable global regulations and standards, including providing support during internal and external audits.
* Conduct periodic line audits to assess production controls such as lot segregation.
* Investigate, document, review, and approve non-conformances, CAPAs, and customer complaints.
* Evaluate accountability and ownership for material identification, material segregation, classification of defect types, and successful application of these techniques in manufacturing.
* Analyze and review the effectiveness of preventive and corrective actions.
* Approve IQ, OQ, PQ, TMV, or software validation.
Education and Experience:
* A minimum of a bachelor's degree in engineering or a related technical field.
* Technical training and experience using statistics, lean, and six sigma methodologies, including measurement system analysis, SPC, DOE, reliability, etc.
* Experience with a proven track record of implementing risk mitigation.
* Understanding of NPI (new product introduction) process and process validation expertise preferred.
* A thorough understanding of GMP/ISO regulations and validation regulations preferred.
* Demonstrated project management and leadership abilities required.