We are currently seeking an exceptional professional to join our award-winning Medical Device organization based in Limerick.
Duties:
* Manage Business Unit Non-Conformance (NC), CAPA, Complaints and Validations to ensure regulatory compliance.
* Investigate and trend NC's and complaints, assessing the need for corrective actions.
* Resolve product holds by conducting investigations and escalating to MRB as necessary.
* Support internal and external audits, serving as a subject matter expert.
* Promote quality improvement initiatives through process and product characterizations.
* Review and analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques, and other improvement tools.
* Evaluate current products and processes for compliance with standards such as QSRs, ISO 13485, and global regulations.
* Champion compliance with applicable regulations and standards, providing support during audits.
* Conduct periodic line audits to assess production controls and review results to ensure adequate corrective actions.
* Investigate, document, and approve non-conformances, CAPAs, and customer complaints.
* Escalate quality issues as necessary and maintain accountability for material identification, segregation, and classification.
* Analyze the effectiveness of preventive and corrective actions, reviewing root cause investigations.
* Maintain ownership of Quality metrics, including leading and lagging indicators.
* Approve IQ, OQ, PQ, TMV, or Software Validation
Education & Experience:
* A minimum of a Bachelor's Degree in Engineering or a related technical field is required.
* Technical training and experience in Statistics, Lean, and Six Sigma Methodologies, including Measurement System Analysis, SPC, DOEs, Reliability, etc., are essential.
* A proven track record of implementing risk mitigation strategies is required.
* Understanding of the NPI process and Process Validation expertise is preferred.
* A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
* Project management and leadership abilities are necessary for success in this role.