Job Title: Quality Manager - Medical DeviceJob Description

A growing medical device organization is seeking a Quality Assurance Manager to lead and enhance its Quality Management System (QMS). This individual will play a central role on a small, collaborative team and work closely with the executive leadership group. The ideal candidate brings experience in medical device quality, strong ownership of compliance activities, and the ability to partner cross-functionally to maintain and improve quality processes. This position is highly visible and critical to ensuring products meet regulatory, safety, and performance standards.

ResponsibilitiesServe as the organization’s Management Representative.Own and manage the company’s Quality Management System (QMS/EQMS), including documentation, updates, and continuous improvement.Manage internal and external audits, including preparation, execution, and follow-up activities; support compliance with FDA and MDSAP requirements.Lead and document post-market surveillance (PMS) activities, including trending of quality data and complaint analysis.Maintain Device History Records (DHR), Device Master Records (DMR), and all associated documentation.Oversee calibration programs, training records, supplier files, and preventive maintenance documentation.Support regulatory submissions for reportable events in accordance with applicable requirements.Prepare Management Review materials.Develop and present quality trending reports, using data from multiple inputs to identify issues, risks, and evaluate personnel, production, inspection, and repair errors to identify patterns and recommend corrective actions.Lead the CAPA process, including initiation, tracking, updates, and closure.Support non-conformance investigations and risk analyses; represent QA in MRB activities.Manage the Document Change Order (DCO) process for procedures, inspection documents, and other controlled files.Ensure timely review and approval of production and incoming inspection records.Manage complaint handling, including intake, investigation, documentation, and escalation.Review reprocessing events and prepare related reports.Maintain external standards/references and conduct gap assessments as needed.Support audits of vendors and distributors.Provide quality training to internal teams.Supervise small QA staff (e.g., Repair Clerk, Quality Coordinator).Essential Skills5+ years of experience in Quality Assurance within the medical device industry.Hands-on experience managing a QMS/EQMS for a regulated medical device manufacturer.Participation in at least five medical device audits (internal, supplier, or regulatory).Strong knowledge of DHR/DMR, CAPA, complaint handling, and documentation control.Experience with post-market surveillance, trending analysis, and quality metrics.Familiarity with FDA 21 CFR 820 and MDSAP.Ability to work effectively in a small-team environment, partnering closely with leadership.Strong organizational, communication, and problem-solving skills.Additional Skills & QualificationsExperience leading audit activities or serving as the primary audit contact.Experience supporting training programs or QMS education.Prior supervisory experience.Work Environment

The role is based in a stable medical device manufacturing company with long-term sales and a family-oriented culture. The Quality Manager will supervise two direct reports. The environment promotes collaboration within a small team and close partnership with leadership.

Job Type & Location

This is a Permanent position based out of Simi Valley, CA.

Pay and Benefits

The pay range for this position is $110000.00 - $125000.00/yr.

medical vision dental 401k

Workplace Type

This is a fully onsite position in Simi Valley,CA.

Application Deadline

This position is anticipated to close on Feb 18, 2026.

About Actalent

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.

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