Type:

full-time

Job Description:

TekPro is partnered with a high-tech aerospace/medical device contract manufacturer in the Bay Area in their search for a Quality Manager! Apply now to be considered for this excellent career opportunity.

Highlights:

High growth, multi-state manufacturing organization with 50+ years in business
This individual is responsible for QMS management, personnel management, customer communication, and hands-on inspection leadership.
Proven experience required in precision machining for medical, aerospace, or other highly regulated manufacturing sectors.

Responsibilities:

Manage the company's Quality Management System and inspection functions
Maintain compliance with

ISO 9001, ISO

13485, and applicable customer requirements

Coordinate internal, customer, supplier, and external audits
Lead management review meetings and internal audit activities
Manage customer complaints, rejects, corrective actions, and quality concerns
Oversee CAPA, nonconformance, deviation, and change control activities
Maintain customer quality documentation, certifications, and reporting
Develop and maintain IQ, OQ, and PQ documentation for applicable equipment and processes
Support SPC, capability studies, and other quality improvement activities
Manage and monitor supplier quality performance
Recruit, train, supervise, and develop Quality Department employees
Establish department goals, metrics, and performance expectations
Work closely with Manufacturing, Engineering, Sales, and other departments to resolve quality issues
Support continuous improvement efforts including 5S, Kaizen, DMAIC, and root-cause analysis
Ensure departmental safety and OSHA requirements are followed

Qualifications:

10+ years of progressive manufacturing, operations, or quality experience
5+ years of Quality Management experience
Strong knowledge of ISO 13485 and

ISO 9001

ISO 13485 or AS9100 Lead Auditor certification preferred
Experience conducting internal, customer, supplier, and external audits
Experience with CAPA, 5 Why, root-cause analysis, and corrective actions
Experience with supplier quality management and auditing
Experience with nonconformance reports, deviations, CAPA, and change requests
Knowledge of SPC and Minitab
Strong understanding of manufacturing processes and quality practices
Strong leadership, communication, organization, and problem-solving skills
Microsoft Office proficiency required
Bachelor's degree preferred

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