1007-208454
Quality team leader Quality Engineer Six Sigma Quality Assurance Medical Devices CAPA FMEA Munster Engineering Cork. QA
Cork Munster
Negotiable
4 - 5 Years
Permanent Full-time
Third Level Degree
01 614 6121
Julio.Garcia@cpl.ie
QA Manufacturing Team Leader
In partnership with its client CPL is currently looking for a QA Team Leader for a Medical Device company in the Munster area.
Reporting to the QA Leader the QA Manufacturing Team Lead will lead from a Quality perspective the production activity on site.
Duties:
- Manage the activities of a defined team of QA personnel. Management responsibilities to include day to day work allocation and prioritisation, performance and output quality review, coaching, training, internal communications and general personnel assistance during the course of their duties
- Actively support all defined Plant goals and objectives.
- Co-ordinate all Six Sigma activities across the site.
- Lead QA Manufacturing on existing products & new product development/transfers.
- Responsible for recruitment, development and training of all QA Manufacturing Support personnel
- Work closely with other areas of QA and the business to promote compliance
- Establish and administer Operator Inspection programme and provide initial training certification as required on an ongoing basis to support objectives
- Maintain manufacturing audit inspection and activity
- Implement and maintain CSOPs to ensure total compliance in areas of responsibility.
- Resolve problems & eliminate constraints to ensure project targets are met.
- Ensure that all relevant Quality Data is recorded, reported and actioned in an efficient manner. (Scrap, MRR etc.)
- Represent QA manufacturing at monthly CAPA meeting.
- Be responsible for the release of product to the sterilization contractor for the plant.
- Ensure that all DHRs are complete and accurate via appropriate system controls
- Identify and carry out required Quality inspection training
- Ensure the plant complies with GMP, ISO and QSR requirements.
- Support preparation of and maintenance of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), Raw Material Specifications (RMS) etc.
- Represent Quality in Planning/Customer Service meetings to support timely delivery of service to ensure continuous supply of good product to distribution.
- Co-ordinate the activities of the QA Manufacturing Support group in managing Operator Certification.
- Ensure effective and timely closure on all Corrective Action Requests, Failure Investigation Reports and Close Call Investigation.
- Maintains standards of housekeeping & GMP requirements
Requirements:
Ø A degree level or similar qualification in mechanical or industrial engineering.
Ø Minimum 3 years in Medical Device Manufacturing in a people management role.
Ø Proven ability to successfully manage QA systems in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations.
Ø CAPA working experience
Ø Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
All applications will be treated with the strictest of confidence
CPL Contact:
To apply or for further information please contact Julio Garcia on +353 1 6146121 or e-mail with you updated CV to julio.garcia@cpl.ie
Keywords: QA, Quality Assurance, Quality Engineer, Quality team leader, Medical Devices, Engineering, Six Sigma, CAPA, FMEA, Munster, Cork.