QA Manufacturing Team Lead
|Job Title:||QA Manufacturing Team Lead|
|Job Published:||about 1 year ago|
Our client a leading medical device manufacturing company located in Cork, requires an experienced QA Team Lead for a permanent job. The QA Manufacturing Team Lead will lead from a Quality perspective the production activity on site
? 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
? Administration/implementation of Traceability for C of C documentation, DHR systems
? 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 resources are available for complaint investigation when required.
? Ensure the plant complies with GMP, ISO and QSR requirements.
? Manage repack from a QA perspective
? Ensure effective and timely communications both oral and written (weekly/monthly written reports, Project updates, daily / weekly direction to Quality personnel)
? 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
? Ensure QA Manufacturing personnel maintain a systematic control of documents.
? Represent the Quality function as required by management
? Ensure that all Health, Safety and Environmental requirements are fulfilled.
? Continuous Improvement Focus
? Continuous Improvement Focus
Qualifications & Experience
? A degree level or similar qualification in mechanical or industrial engineering.
? Minimum 3 years in Medical Device Manufacturing in a people management role.
? Proven ability to successfully manage QA systems in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations.
? Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
? Proven experience and training n Light Mechanical Engineering processes ? machining ? casting ? forging etc.
For further information on this QA Manufacturing Team Lead role in Cork please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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