Quality Manager

Quality Manager

Job Description

The Quality Manager leads and continuously improves the companys quality management system (QMS) to ensure full compliance with FDA regulations, ISO standards, and other applicable regulatory requirements within the medical device industry. This role oversees quality engineering, quality assurance, and quality control activities, drives effective corrective and preventive actions, and partners closely with cross-functional teams to embed quality into every stage of the product lifecycle. The Quality Manager serves as a key liaison during internal and external audits and provides clear, data-driven quality insights to senior leadership.

Responsibilities

• Lead, maintain, and continually improve the companys quality management system (QMS) in compliance with FDA regulations, ISO standards, and other applicable regulatory requirements.

• Plan, manage, and host internal and external audits, including FDA inspections and ISO certification audits, ensuring audit readiness at all times.

• Oversee corrective and preventive action (CAPA) processes, nonconformance investigations, and complaint handling to ensure timely, effective, and compliant resolutions.

• Collaborate with cross-functional teams, including Research and Development, Manufacturing, and Regulatory, to ensure quality is built into every stage of the product lifecycle.

• Develop, track, and analyze quality metrics and key performance indicators (KPIs), and present findings, trends, and recommendations to senior leadership.

• Lead and coordinate training programs on quality standards, procedures, and best practices to ensure organization-wide understanding and adherence.

• Manage document control and change control processes to maintain accurate, current, and compliant quality documentation and records.

• Oversee risk management processes, ensuring that product and process risks are identified, evaluated, and mitigated in accordance with applicable standards.

• Supervise quality assurance and quality control staff, providing coaching, guidance, and performance feedback to build a high-performing quality team.

• Support and lead root cause analysis activities to identify underlying issues and implement sustainable corrective and preventive actions.

• Participate in and lead special projects and other duties as assigned to support broader organizational goals related to quality and compliance.

Essential Skills

• Bachelors degree in Engineering, Life Sciences, or a related field.

• 5+ years of experience in quality management within the medical device industry.

• Strong knowledge of FDA Quality System Regulation (QSR) and relevant ISO-based quality management system requirements.

• Demonstrated experience managing and maintaining a quality management system (QMS) in a regulated environment.

• Hands-on experience with CAPA processes, including initiation, investigation, implementation, and effectiveness verification.

• Proficiency in root cause analysis methodologies and tools to resolve quality issues and prevent recurrence.

• Experience preparing for and managing internal and external audits, including regulatory inspections and ISO certification audits.

• Solid background in quality engineering and quality assurance practices within medical device manufacturing.

• Strong understanding of risk management principles and their application in product and process development.

• Excellent leadership skills with experience supervising or leading quality assurance and quality control staff.

• Effective written and verbal communication skills, with the ability to present quality metrics and findings to senior leadership.

• Strong problem-solving and analytical skills, with the ability to interpret data and drive evidence-based decisions.

Additional Skills & Qualifications

• Masters degree in Engineering, Life Sciences, or a related field is preferred.

• Familiarity with aerospace quality standards such as AS9100 is beneficial, especially for organizations serving multiple regulated markets.

• Experience developing and delivering training programs on quality standards, procedures, and best practices.

• background in medical device quality systems, including complaint handling, nonconformance management, and audit readiness.

• ASQ certifications, such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA), are a plus.

• Demonstrated ability to collaborate effectively with cross-functional teams, including R&D, Manufacturing, and Regulatory.

• Proven capability to develop, monitor, and report on quality metrics and key performance indicators (KPIs).

Work Environment

The Quality Manager works in a regulated medical device environment that emphasizes compliance, documentation integrity, and continuous improvement. The role involves close collaboration with cross-functional teams such as Research and Development, Manufacturing, Regulatory, and quality assurance and quality control staff. Work typically takes place in an office and manufacturing or laboratory setting where access to quality documentation systems, QMS tools, and audit preparation materials is essential. The position requires regular participation in internal meetings, audit activities, and training sessions, as well as periodic interaction with external auditors and regulatory representatives. The environment is structured, detail-oriented, and process-driven, with a strong focus on maintaining high product quality and meeting regulatory expectations.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $130000.00 - $150000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

health, dental, vision, pto, sick pay, retirement plan, and more

Job Type & Location

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

Application Deadline

This position is anticipated to close on Nov 17, 2026.

Workplace Type

This is a fully onsite position in Lawndale,CA.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.