Description
Summary:
Lead validation and related programs to ensure regulatory compliance and effectiveness of facilities, equipment, and processes.
Responsibilities:
1. Provide technical leadership, expertise and guidance to major functions (e.g. product development, corporate or facility manufacturing, product development.
2. Coach, train, and provide guidance to other engineers in areas of expertise.
3. Lead continuous improvement activities for the validation program to ensure efficiency, effectiveness and compliance. Initiate corrective action and product, service, and quality system improvements.
4. Develop Validation Master Plans and project plans and maintain project schedules.
5. Lead manufacturing process validations, test method validations, process capability studies, and process improvements.
6. Select and utilize a wide range of appropriate statistical methodologies and techniques.
7. Establish inspection criteria for new and modified products.
8. Establish design limits for new and modified products, including the use of design of experiments (DOE)and the identification of critical variables.
9. Lead failure investigations and problem solving acticities regarding customer complaints, non-conforming materials, and vendor quality problems to improve quality, reliability and cost.
10. Conduct or support the development or hazard analyses, design and process FMEAs and issue/event-based risk assessments. Ensure their compliance with Arrow's policies and procedures.
11. Perform formal supplier quality evaluations; conduct suppler and internal quality audits as requested.
12. Design, conduct, and report on gage repeatability and reproducibility studies.
13. Coordinate facility and maintenance activities to facilitate improvements and repairs.
14. Review and, as appropriate, modify quality system documentation to ensure compliance and effectiveness.
15. Defend personal qualifications and work output during FDA and customer audits.
16. Adhere to the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
Requirements
1. A minimum of 10 years experience in process validation, quality assurance/quality, or reliability engineering functions commensurate with the responsibility outlined above.
2. A minimum of one year experience in the medical industry.
3. Ability to train, mentor and coach others.
4. Knowledge of ASQ, ANSI, AAMI, and AST standards and guideline documents.
5. Knowledge of sampling plans, inspection criteria and techniques, critical attributes, process validations, statistical methods, disposition of non-conforming product, trending methods, environmental monitoring.
6. Experience and knowledge of lean manufacturing, six sigma, design of experiments, cost of quality tools and techniques, and failure investigation methods.
7. Knowledge and experience with statistical process control, defects-per-million, and other process monitoring methods and techniques.
8. Able to travel domestically and internationally.
EOE.
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