We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
− Business Unit Non-Conformance (NC), CAPA, Complaints and Validations management
− This includes investigations related to NC’s and complaints, trending of same and assessing need for CAPA.
− Responsible for investigation/disposition of on hold product and material (including supplier related holds) up to and including escalation to MRB
− Support both Internal and external audits, act as Business Unit Subject Matter Expert
Business Improvements
− Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
− Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
Compliance/Regulatory
− Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
− Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
− Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
Product Quality, Control & Disposition and Performance Standards
− Conduct investigation, bounding, documentation, review, and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
− Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
− Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
− Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Product/Process Qualification
− Approve IQ, OQ, PQ, TMV or Software Validation
Education & Experience
− A minimum of a Bachelors Degree, preferably in Engineering or related technical field.
− Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
− Experience with a proven track record of implementing appropriate risk mitigation.
− Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
− A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
− Demonstrated project management and project leadership abilities are required.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
