Job Description
Job Title: Quality Manager
Job Description
We are seeking an experienced Quality Manager to lead and maintain our Quality Management System (QMS) in compliance with FDA and other regulatory requirements. This role involves managing audits, overseeing quality processes, and collaborating with cross-functional teams to ensure product excellence.
Responsibilities
+ Lead and maintain the company's QMS in compliance with FDA and other regulatory requirements.
+ Manage internal and external audits, including FDA inspections and ISO certification audits.
+ Oversee CAPA, nonconformance, and complaint handling processes.
+ Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory) to ensure quality is built into every stage of the product lifecycle.
+ Develop and monitor quality metrics and KPIs; report findings to leadership.
+ Lead training programs on quality standards, procedures, and best practices.
+ Manage document control, change control, and risk management processes.
+ Supervise quality assurance and quality control staff.
+ Other duties and special projects as assigned.
Essential Skills
+ Quality engineering
+ Quality assurance
+ Root cause analysis
+ Medical device industry experience
+ CAPA
+ Quality management
+ AS9100
+ Quality management system
Additional Skills & Qualifications
+ Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
+ 5+ years of experience in quality management within the medical device industry.
+ Strong knowledge of FDA QSR and risk management (ISO standards).
+ Experience with CAPA, root cause analysis, and audit readiness.
+ Excellent leadership, communication, and problem-solving skills.
+ ASQ certifications (e.g., CQE, CQA) are a plus.
Work Environment
This position involves working closely with cross-functional teams and requires strong collaboration skills. The work environment prioritizes compliance with regulatory standards and continuous improvement. Typical office attire is expected.
Pay and Benefits
The pay range for this position is $130000.00 - $150000.00/yr.
- Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).- 5+ years of experience in quality management within the medical device industry.- Strong knowledge of FDA QSR, ISO 13485, and risk management (ISO 14971).- Experience with CAPA, root cause analysis, and audit readiness.- Excellent leadership, communication, and problem-solving skills.- ASQ certifications (e.g., CQE, CQA) are a plus.
Workplace Type
This is a fully onsite position in Lawndale,CA.
Application Deadline
This position is anticipated to close on Aug 7, 2025.
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.
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
[email protected] (%
[email protected]) for other accommodation options.
Job Tags
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