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Job Details
12 Month Fixed Term Contract
Day to Day Activities
路Taking direction from Quality Engineer鈥檚/Quality Team Leader as to how best to deploy resources and effort on the operations floor. 路Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures. 路Daily production line monitoring and the identification and quantification of process problems, along with subsequently implementing the necessary improvements and/or controls 路Regular communication with the Manufacturing Team Members regarding issues, concerns and watch-outs on the lines.- Actively interfacing with cross-functional team members and suppliers, and always practicing good team work in support of the day to day operating requirements, and in pursuit of achieving the business targets
Inspection
- Assist in the develop and maintenance of sampling and inspection procedures
- Sample, inspect and record inspection results when required
- Control movement of components / products following inspection
- Conduct MRB forums
Quality Improvements
- Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
- Support implementation of plant wide quality system improvements.
- Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.
- Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.
Manufacturing Support
- Support Manufacturing Cell in addressing Quality Metrics, e.g. e.g. CAPA, Validations, NCR, Quality Awareness Tests, Training, ECR鈥檚 and Internal Audit AG真人百家乐ings.
- Responsible for input to Quality Metrics
- Participate in the development and Continuous Improvement of the manufacturing processes for existing and new products. Coordination of PPAP activities.
- Provide functional expertise to other support function on quality related issues.
- Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
- Coordination of MRB activities to the business unit to ensure the timely assessment of potential non-conforming products.
- In conjunction with Team Lead approval, has the authority to order the cessation of production and product shipments in the event of a non-conformance arising. 聽In conjunction with Team Lead approval, also has the authority to order the recommencement of production provided he/she is satisfied that all issues pertaining to the non-conformance have been addressed.听听
- Support the creation & presentation the Monthly Business Unit review Slides and Represent Quality at this forum.
- Represent Quality at the Weekly FPY (First Pass Yield) forum; Review the FPY Slides for trends and update as required from a Quality perspective
Customer Complaints
- Give input into the evaluation of Customer Complaints (PER Investigation) as required.
- Problem solving / Trouble shooting of customer complaint investigations, coordination of root cause and risk assessments associated NC鈥檚 and Risk Assessments where required.
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NCR/CAPA
- Support the NCR/CAPA Process.
- Participate in risk assessment activities and ensure that all failure modes in process have been identified and addressed.
- Participate in Problem Solving meetings using the following: 4D, Six Sigma, etc.
- Ensure that Containment of product is properly addressed and Documented
- Ensure that Corrective Actions clearly actioned and documented.
Validation
- Assist in completion of equipment validation ((VP, IQ, OQ, PQ, MSA, IPF鈥檚, PSP鈥檚, FR鈥檚 etc.).
- QA review and approval of unplanned Pemac routines.
Auditing
- Participate in Internal Audits as required and Supplier Audits. if required.
- Support site during External Audits. (i.e. FDA, IMB and BSI).
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Risk:
- Understand and ensure compliance to ISO 14971 鈥楻isk management鈥�.
- Ensure that the Top Down Risk Documents, Bottom Up Risk Documents and Attribute Charts are current and live.
Company Details

Stryker
Kalamazoo, MI, United States
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative... Read more