Exciting Opportunity with a Leading Medical Device Organization
We are 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.
* 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.
* 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.
* 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.
* Analyse/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
* 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.