Manager, Regulatory and Quality Systems
Precision Technologies, a division of Benchmark Electronics, Inc. Precision Technologies Tempe 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 Capabilities The Quality Manager 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.
4-year college technical degree or equivalent combination of education and experience.
Job ID(Requisition ID): 3043