Quality Manager

Quality Manager Job Description

We are seeking a dedicated Quality Manager to manage and execute all activities of the quality management system. This role involves ensuring compliance with FDA and ISO standards, acting as the Management Representative, and overseeing continuous improvement processes.

• Implement and maintain a quality system in compliance with FDA and ISO standards.
• Serve as the Management Representative with authority and responsibility to the President/CEO for the company's quality management system.
• Assess the effectiveness of the quality management system and implement necessary modifications to achieve quality compliance.
• Act as the external liaison for all quality-related correspondence, meetings, and audits with notifying bodies, regulatory agencies, and customers.
• Oversee the Management Review process to inform management about the quality management system status and identify improvement opportunities.
• Coordinate the internal audit program and ensure effective corrective actions are documented and implemented.
• Lead Root Cause and Corrective Action (RCCA) teams to conduct failure analysis and recommend corrective actions.
• Manage the Corrective Action and Preventive Action (CAPA) program for its continuing effectiveness.
• Coordinate the Material Review Board (MRB) to disposition products and guide corrective action efforts.
• Investigate customer complaints and develop plans to address issues affecting customer satisfaction.
• Coordinate support for quality-related inputs to new product development.
• Ensure timely calibration and recall of all tools, gauges, and test equipment.
• Coordinate the validation and qualification of all equipment, products, and processes with engineering and manufacturing.
• Manage the supplier evaluation and qualification system and perform quality audits of the supply chain.

• Bachelor's degree or equivalent experience required.
• Minimum of five years quality assurance/control management experience in a regulated environment.
• Experience with SPC, FMEA, and process validation is highly desired.
• Quality engineering or manager certification (CQE or CQM) is desirable.
• At least three years in the medical device or related industry.
• Working knowledge of shop math and statistical concepts.
• Ability to read, analyze, and interpret complex drawings and documents.
• Proficient in Microsoft Office and general P/C skills.
• Excellent communication skills, both written and verbal.

• Proficiency in statistical inference and probability.
• Knowledgeable in fundamentals of plane/solid geometry and trigonometry.
• Ability to apply mathematical concepts to quality situations.

This role requires collaboration with various teams in a regulated environment. You will be engaging with engineering and manufacturing teams, and working with advanced quality systems and processes. Proficiency in Microsoft Office and the ability to handle complex technical documentation is essential.

This is a Permanent position based out of Valencia, CA.

The pay range for this position is $100000.00 - $120000.00/yr.

Company internal benefits.

This is a fully onsite position in Valencia, CA.

This position is anticipated to close on Jan 23, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.