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Plant Quality Manager IL Open (J#25826)

Title: Plant Quality Manager
Company: Covidien
Salary: Open

Job Description

Position Summary

This position is responsible for the overall Quality System function for the plant in Crystal Lake, IL.

Ensures adherence to and compliance with established company quality policies, practices, SOPs and federal regulations. Provides strategic direction and policies for QA operations. Translates business goals to quality function goals. Accountable for ensuring all quality standards are met, including determining product conformance to specification; establishing the laboratory and facilities needed for product inspection and testing; selection and training of technicians, and Quality Engineers to evaluate product and make conformance decisions. Borderline anddebatable issues come to the Quality Manager for resolution. Provides data on product quality to suppliers and production personnel. Assists in troubleshooting and in finding remedies. Assists quality improvement teams through collecting and providing data and recommending solutions. Leads the Internal Audit function. Helps to establish conditions, which make it possible to delegate greater autonomy to Production (self-control and self-inspection). Stimulates within the Quality Department an attitude of service to others. Strong knowledge and understanding of FDA and ISO regulatory requirements.

Principal Accountabilities
- Develop, recommend, implement, and administer quality policy as directed by corporate policy and local procedures. - Manage and direct in-plant Quality Assurance operations. (Complaints, CAPA, internal audit, documentation, MRB, etc.) - Be responsible for meeting all Plant Quality Assurance metrics required by the management, including but not limited to On-time Complaints closure, CAPA closure, timely response to Medical device reports, Vigilance reports, RFAIs, Vendor and Customer Audits, NCRs, MRBs, personnel training, risk management, cost of quality, process changes, design changes, and Validations. - Provide guidance to the QA department and plant personnel to implement sound quality assurance principles and techniques for maintenance of Clean room and/or controlled manufacturing environment. - Be the mentor and provide guidance and expertize to the plant QA team, Engineering and manufacturing teams on Quality Assurance regulations, tools, techniques, FDA QSR regulations, validation, verifications, calibration etc. - Be the subject matter expert from Quality Assurance management perspective. - Develop and apply knowledge and expertise in Plastic injection molding and high speed automated assembly / manufacturing environment. - Provide technical assistance to plant management.Provide expertise and guidance to ensure plant meets the expectations from a Class I and Class II medical devices manufacturing requirements. - Provide guidance to plant personnel to implement sound quality assurance principles and techniques forimplementation of a robust Quality management system and Quality engineering processes and systems. - Primary host and respondent to F.D.A. Inspectors and ISO and corporate audits. - Quality System Management representative with authority and primary or secondary responsibility for all applicable ISO elements. - Assures plant compliance with all GMP, ISO, CMDR and other regulatory requirements. - Preparation of annual QA budget. - Review the QA operation and implement cost reductions where appropriate. - Coordinate supplier audits when necessary. - Maintain knowledge of regulatory requirement. - Provide organization and direction to the Quality Assurance department team. - Create programs to improve quality, reduce costs and improve customer satisfaction. - Interface with other departments to assure that quality considerations and regulatory requirements are adequately covered in procedures, equipment selection, design, validation, supplier selection, and training. - Be a solution provider.
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