we are looking for a Quality Manager, Engineering & Manufacturing
Lead Sr. Quality Eng., team leaders, Quality Engineers and Quality personnel in the day-to-day activities- supervise performance and tasks handling, set priorities, training, and objectives according to the organizational goals.
Lead Sr. Quality Engineers and QEs who review and approve technical/ Engineering documentation (DMR, IQ, OQ, PQ, product specifications, process validation and qualification activities, FMEA risk documents, test methods, protocols, reports, OOSs, design transfer, etc.) in relation to medical devices.
Lead the Quality involvement in design and maintenance of product and production process and hazard analysis in accordance with West policies and procedures.
Provide Quality oversight and guidance to design transfer and process qualification and validation activities to other Sr. QEs.
Provide quality oversight, approval and guidance for qualification documentation and reports
Provide direction and guidance with problem solving techniques for technical and process reviews in cases of escalations.
Lead the sites device sterilization methods establishment, validation, maintenance and routine controls as the site sterilization SME by verifying that the sterilization methods validation is done according to the applicable standards and regulations. Verify the sterilization methods and risk-based approach are routinely maintained. Address sterilization issues and provide solutions to sterilization challenges. Be a part of the West Global Sterilization Council and provide support to other West CM and Medical device sites with Sterilization issues. Be key focal point with the West IL sterilization service providers related to sterilization matters.
Lead Sr. Quality Engineer who is responsible for Manufacturing Quality Engineers presence at the Contract Manufacturing, audit processes and production controls, onsite GMP inspections, failure investigations (NCMR), verify compliance with Wests production, inspection, and maintenance procedures.
Lead Sr. Quality Supervisors who are responsible for Quality personnel oversight over production controls, calibration, raw material acceptance, auditing production related documentation, DHR, batch records, labelling release, finished products release to market (including review and approval of sterilization and Endotoxin testing documentation) .
Drive and support continuous quality improvement projects, lead projects related to CoPQ, Right First Time, etc.
Work cross-functionally with other team managers and project teams leaders to provide QA guidance and ensure success of projects.
Provide guidance with customer meetings and support escalations related to customer issues to QA aspects of, sterilization, production nonconformities and process validation.
Review and approve QMS procedures, waivers, NCMR, failure investigations, product specifications, ECOs/DCOs, risk analysis and software validations.
Support QMS activities including CAPA, Failure Investigation, OOS, Non-Conformance assessment, internal/external audits, or Other duties as assigned
Adhere to all company policies.
דרישות:
B.Sc. in Engineering or Science required
Minimum 10 years working in Medical Device / Pharma industry- in Quality roles
Minimum 8 years working in the areas of design controls/process validation
Experience with customer interface and meeting customer expectations
Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
Must have an in-depth knowledge of product verification and process validations in a Medical Device environment
Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
Knowledge in applicable sterilization standards and methods, such as ISO 11137 and ISO 11135
Excellent written and oral communication skills
Excellent critical reading and writing skills
Must have eff המשרה מיועדת לנשים ולגברים כאחד.
