Job Description:
We are seeking a highly skilled Quality Professional to join our team at an award-winning Medical Device organization based in Limerick.
This is an excellent opportunity for individuals looking to work with a leading multinational that excels in its field.
Duties:
* Manage Business Unit Non-Conformance (NC), CAPA, Complaints, and Validations
* Investigate NC's and complaints, trend analysis, and assess need for CAPA
* Responsible for investigation/disposition of on hold product and material up to MRB escalation
* Support Internal and external audits as Business Unit Subject Matter Expert
* Spearhead quality improvement initiatives such as process and product characterizations for continuous/cost improvements
* Review/analyze PDCA, Six Sigma, Kaizen, Lean Techniques, and other improvement tools
* Evaluate compliance to standards like QSRs, ISO 13485, and review current products/processes
* Champion compliance to Global Regulations and standards, providing support during internal and external audits
* Conduct line audits to assess production controls, review area audit results, and ensure corrective actions
* Investigate, document, and approve non-conformances, CAPAs, and customer complaints, escalating quality issues as necessary
* Owning accountability for material identification, segregation, classification of defect types, and successful application in manufacturing
* Analyze/review effectiveness of preventive and corrective actions, root cause investigations
* Maintain and review Quality metrics, including leading/lagging indicators of quality
* Approve IQ, OQ, PQ, TMV or Software Validation
Education & Experience:
* Bachelor's Degree in Engineering or related technical field (minimum)
* Technical training and experience using Statistics, Lean, and Six Sigma Methodologies required
* Proven track record of implementing risk mitigation strategies
* NPI process understanding and Process Validation expertise preferred
* GMP/ISO regulations and validation regulations understanding preferred
* Demonstrated project management and leadership abilities required
Key Requirements:
* $80,000 - $110,000 annual salary
* Location: Limerick, Ireland