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Director Quality Engineer Fda Jobs (NOW HIRING)

Masimo

Director, Quality Systems

Irvine, CA · On-site

The Director partners cross-functionally with Quality, Regulatory, Engineering, Operations ... FDA 21 CFR Part 803 and 806 * ISO 13485 * EU MDR * MDSAP * Risk-based quality methodologies

Danaher

Principal AI Quality Engineer

Vista, CA · On-site

This position reports to the Director, Quality Assurance and Regulatory Compliance and is part of ... Support global regulatory submissions, such as FDA pre subs, 510(k), and IVDR CE, while driving AI ...

Spectrum Staffing Services

Be Seen First

Quality Engineer

Raleigh, NC · On-site

$43 - $45/hr

Support, maintain, and improve the Quality Management System (QMS) in compliance with FDA, ISO ... Opportunity to make a direct impact on product quality and patient safety. * Exposure to new ...

Danaher

Principal AI Quality Engineer

Vista, CA · On-site

This position reports to the Director, Quality Assurance and Regulatory Compliance and is part of ... Support global regulatory submissions, such as FDA pre-subs, 510(k), and IVDR CE, while driving AI ...

Iridex Corporation

Quality Engineer

Mountain View, CA · On-site

$112K - $120K/yr

Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...

Iridex Corporation

Quality Engineer

Mountain View, CA · On-site

$112K - $120K/yr

Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...

Convergent Dental, Inc.

Quality Engineer

Waltham, MA · On-site

$90K - $135K/yr

Ensure compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part ... Director of Quality and Regulatory ABOUT CONVERGENT DENTAL: Convergent Dental, Inc. is a privately ...

Actalent

Quality Engineer

Minneapolis, MN · On-site

$43 - $53/hr

Ensure compliance with FDA regulations, ISO standards, and applicable medical device requirements ... Make a direct impact on patient safety and product quality. * Lead high-visibility investigations ...

Smiths Machine

Quality Engineer

Huntingdon Valley, PA

$70K - $91K/yr

Ensure compliance with ISO 13485 and FDA quality system regulations * Evaluate design and process changes for impact to Design History Files (DHF) and lead gap closure activities * Develop and ...

Imperative Care

Director Quality Assurance

Campbell, CA · On-site

$234K/yr

Bachelor's degree in engineering or related discipline and a minimum of 10 years of progressive ... Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO ...

Align Technology

Director, Quality Systems

San Jose, CA · On-site

$196K - $269K/yr

Master's degree in Quality Management, Engineering, or a related field, or Bachelor's degree with ... Demonstrated expertise in FDA regulations, including QSRs, and relevant international standards ...

Align Technology

Director, Quality Systems

Raleigh, NC · On-site

Master's degree in Quality Management, Engineering, or a related field, or Bachelor's degree with ... Demonstrated expertise in FDA regulations, including QSRs, and relevant international standards ...

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Director Quality Engineer Fda information

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How much do director quality engineer fda jobs pay per year?

As of Jul 13, 2026, the average yearly pay for director quality engineer fda in the United States is $84,039.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $93,000.00 per year, depending on experience, location, and employer.

What is the difference between Director Quality Engineer Fda vs Quality Engineer Fda?

AspectDirector Quality Engineer FdaQuality Engineer Fda
CredentialsTypically requires a Bachelor's degree in Engineering or Life Sciences, with certifications like ASQ CQE or ISO auditorRequires similar degrees and certifications, often entry to mid-level
Work EnvironmentLeads quality teams, oversees compliance, and strategic planning in manufacturing or biotech settingsPerforms hands-on quality testing, inspections, and process improvements
Industry UsageCommonly used in regulated industries like pharmaceuticals, biotech, and medical devicesUsed across manufacturing, biotech, and pharmaceutical companies for quality assurance

The main difference is that the Director Quality Engineer Fda holds a leadership role with strategic responsibilities, overseeing quality systems and compliance, while the Quality Engineer Fda focuses on operational quality tasks and testing. Both roles require similar credentials but differ in scope and seniority.

What cities are hiring for Director Quality Engineer Fda jobs? Cities with the most Director Quality Engineer Fda job openings:
What are the most commonly searched types of Quality Engineer Fda jobs? The most popular types of Quality Engineer Fda jobs are:
What states have the most Director Quality Engineer Fda jobs? States with the most job openings for Director Quality Engineer Fda jobs include:
Director Quality Engineer Fda jobs near you
Infographic showing various Director Quality Engineer Fda job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, 1% Temporary, and 1% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.
Director, Quality Systems

Director, Quality Systems

Masimo

Irvine, CA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 10 days ago

Job description


Job Summary
The Director, Quality Systems is responsible for leading and advancing the company's Quality Systems strategy, governance, and operational effectiveness to ensure ongoing compliance with global regulatory requirements and industry standards. This role provides leadership and oversight for key quality system functions, including but not limited to Health Hazard Evaluations (HHE), and nonconformance management. This position will support all quality systems processes, including but not limited to computer software assurance (CSA), corrective and preventive actions (CAPA), change control, document control, training, quality metrics and trending, and quality system continuous improvement.
The Director partners cross-functionally with Quality, Regulatory, Engineering, Operations, Clinical, and Information Systems to strengthen quality system performance, mitigate compliance risks, and support product quality and business objectives across the organization. This leader is responsible for driving consistency, accountability, inspection readiness, and continuous improvement while building and developing a high-performing quality systems team.
Duties & Responsibilities
  • Lead and oversee Quality Systems activities to ensure compliance with internal procedures, applicable regulatory requirements, and international quality standards.
  • Provide strategic and operational leadership for core Quality Systems processes, including HHE, nonconformance management, metrics and trending, and management review support.
  • Drive continuous improvement initiatives to strengthen effectiveness, scalability, and efficiency of the Quality Management System (QMS).
  • Monitor quality system performance through data analysis, KPI development, trend reviews, and risk-based metrics to identify opportunities for improvement and proactive mitigation.
  • Partner with Regulatory Affairs, Engineering, Manufacturing, Supply Chain, Clinical, and other cross-functional teams to ensure quality systems are effectively integrated into business and product lifecycle processes.
  • Support internal audits, external audits, customer audits, and regulatory inspections, ensuring readiness, effective coordination, timely response, and sustainable corrective actions.
  • Ensure quality systems align with applicable regulatory requirements, including FDA, ISO, MDSAP, and global medical device regulations.
  • Evaluate and mitigate quality and compliance risks through strong governance, escalation, and risk-based decision-making.
  • Develop, review, and approve policies, procedures, work instructions, and quality system documentation to support compliance and operational excellence.
  • Ensure management is appropriately informed of quality system performance, emerging risks, and improvement opportunities.
  • Drive consistency and harmonization of quality systems practices across sites, functions, and applicable business areas.
  • Lead quality system-related projects, system enhancements, and process improvement initiatives to support growth, efficiency, and regulatory compliance.
  • Collaborate with Information Systems and business stakeholders on validation, implementation, or improvement of systems impacting quality processes.
  • Build, mentor, and develop a high-performing team of quality professionals, fostering accountability, engagement, and continuous development.
  • Provide leadership support for quality-related escalations, issue resolution, and compliance-related decision-making.
  • Perform other duties and special projects as assigned.

Minimum & Preferred Qualifications and Experience:
Minimum Qualifications
  • 10+ years of progressive experience in Quality Assurance, Quality Systems or Quality Compliance within a regulated medical device or life sciences environment.
  • 5+ years of leadership experience managing direct reports, managers, or cross-functional quality teams.
  • Strong knowledge of Quality Management Systems (QMS) principles and regulated quality processes.
  • Deep understanding of applicable regulatory and industry requirements, including but not limited to:
    • FDA 21 CFR Part 820 / Quality System Regulation
    • FDA 21 CFR Part 803 and 806
    • ISO 13485
    • EU MDR
    • MDSAP
    • Risk-based quality methodologies
  • Experience leading HHE and nonconformance processes.
  • Strong experience in CAPA, change control, quality metrics, and process improvement initiatives.
  • Demonstrated ability to analyze quality data, trends, and performance indicators to support risk-based decision-making and process improvements.
  • Strong project leadership experience with cross-functional initiatives and enterprise process improvements.
  • Excellent verbal and written communication skills with the ability to influence and collaborate effectively across all levels of the organization.
  • Strong leadership, organizational, problem-solving, and decision-making skills.
  • Ability to manage multiple priorities in a fast-paced, highly regulated environment.
  • Ability to travel up to approximately 5-10%.

Preferred Qualifications
  • Experience in global or multi-site Quality Systems oversight.
  • Experience supporting enterprise quality system harmonization or transformation initiatives.
  • Experience with electronic quality systems (eQMS), validation activities, and systems impacting regulated processes.
  • Lead Auditor, Certified Quality Auditor (CQA), RAC, or equivalent quality/regulatory certifications preferred.
  • Experience within innovation-driven or high-growth medical device organizations preferred.

Education
Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline required. Master's degree in Engineering, Quality, Regulatory Affairs, Business, or a related field preferred.
Compensation
The anticipated salary range for this position is $170,000 - $210,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 20% annual bonus based on Company, department, and individual performance. Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center, Café. All benefits are subject to eligibility requirements.
Language requirements
  • Ability to read, write, and communicate effectively in English.
  • Ability to interpret technical documents, schematics, and written instructions.
  • Ability to clearly document technical findings and communicate with cross-functional team members.

Physical requirements/Work environment
This position primarily works in a laboratory environment. It requires frequent sitting, standing, and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities.
The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
Masimo is an Equal Employment Opportunity Commission / Affirmative Action Employer. We encourage Minorities, Females, Disabled and Veterans to apply.
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About Masimo

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

1,001 - 5,000 Employees

Headquarters location

Irvine, CA, US

Year founded

1989

Social media

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