Manager, Regulatory And Quality Systems

Benchmark Electronics Fremont , CA 94537

Posted 2 months ago

Precision Technologies, a division of Benchmark Electronics, Inc.Precision Technologies Fremont has an extensive capability in mechanical manufacturing. Our customers are leading Original Equipment Manufacturers who require exacting precision mechanical production capabilities.

Our product lines include the, Aerospace, Healthcare Scientific Instrumentation, and complex electro-mechanical equipment. Our Capabilities Include: Precision CNC 5-Axis Milling and Turning Precision 5-Axis Grinding of Aerospace Turbine Engine Nozzles and Blades Close Tolerance (Micron level) Instrumentation Grinding Electrical Discharge Machining (EDM) NADCAP approved Complex Electro-Mechanical assembly and test (Class 1K & 10K clean room) Functional testing Medium to Large Coordinate Measuring CapabilitiesThe Manager of Quality and Regulatory Systems will Manage Quality Systems Support by developing, implementing, and maintaining current and future Product/Process Inspection and Audits and may be responsible for site regulatory compliance and programs, and serve as divisional and Corporate Quality technical expert as required. Foster divisional teamwork within a continuous improvement environment

Essential Functions and Competencies

  • Capable of training regulatory and quality system requirements, concepts, auditing methods, and quality procedures within the Division and as required to support the Corporation. May manage ESD capability and programs, assuring compliance with and conformance to applicable ESD divisional requirements and commercial standards.

    May be able to provide day to day work direction for the ESD coordinator, and Production/Process Auditor team leader. Demonstrates effective customer interface skills. Demonstrates confidentiality Works with minimal supervision and guidance. Demonstrates effective interpersonal skills.

Qualifications / Education / Experience

  • Participates and contributes to quality departmental management meetings and goal accomplishment. Serves as technical support expert for external regulatory systems audits and customer audits/questions related to QSR and FDA requirements. Assists with the development and implementation of regulatory policy and procedures compliant with required standards within the Division and Corporation as required. Develops monitors and reports on key quality and performance indicators as related to Production/Process audit results. In conjunction with Manager Regulatory Systems, keeps updated on latest and future regulatory requirements, communicating to the division and corporation regulatory needs now and in the future. Champions selected continuous improvement initiatives. Recommends and selects new hires as well as recommends and performs disciplinary actions up to and including terminations.
    8+ years quality and regulatory experience; 3+ years in a leadership role in a multiple or large site.Attention Search Agencies:Please note that we are not accepting agency phone calls or referrals regarding position vacancies. Third parties should not submit resumes on this site or to Benchmark employees directly. If the decision is made to engage the services of a search agency, we only work with organizations on our preferred vendor list with whom we have a written agreement. If you would like to be considered for this list in the future please contact the local Human Resource office.
    4-year college technical degree or equivalent combination of education and experience.
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Manager, Regulatory And Quality Systems

Benchmark Electronics