Job Description
An excellent opportunity for a motivated and driven Quality professional who is looking for a company that allows ownership, accountability, and continuous development.
One of the world's leading medical solution providers seeks a Quality Team Lead to join their expanding operations in Cork. If you have 4+ years' experience in regulated manufacturing (pharma, medical device, or electronics) and enjoy supporting, leading, and developing a team, this could be the role for you.
This fast-paced environment is suited to proactive individuals who work independently. The company invests in its people and offers exposure to business leads in this role.
The main focus is providing QA support to Operations and implementing process improvements from a QA standpoint.
* Supervision of Quality Technicians and Quality Engineers
* Drive and implement process improvements (Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities)
* Provide effective and responsive QA support to Operations to meet quality, cost, and output objectives
* Ensure all failure modes in processes are identified and addressed (DOE studies, FMEA's)
* Drive and implement plant-wide quality system improvements
* Ensure Regulatory compliance in area of responsibility to cGMP's (FDA and TUV)
* Approval of change requests for product, process, and quality system changes
* Customer complaints: Approval of analysis reports and analysis of complaint trends
* Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols, and reports approval
* Compilation of required Regulatory documentation (Technical files, Design Dossiers, Product transfer files, Essential requirements)
* MRB: Review of MRB trends and identification of appropriate corrective actions when required
* Perform internal quality audits
* Support the implementation of Lean Manufacturing across the site
* Transfer and implement product and processes from development or another manufacturing facility
* Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities
Education/Experience:
* Requires a minimum level 8 qualification in a relevant Engineering/Science degree
* Excellent interpersonal and communication skills
* Ability to work as part of a team and meet targets/goals efficiently
* Excellent analytical and problem-solving skills
* Demonstrated decision-making skills
* Minimum of 4+ years' experience within a manufacturing environment
* People management experience is advantageous
* Strong knowledge of quality principles and ability to utilize these methods in a manufacturing environment