Top 24 Director of quality Jobs in Orange County Ca

Director, Quality Systems
Masimo —Irvine, CA
- $170,000 - $210,000 a year
- Full-time
- Schematics
- 5 years
- Computer literacy
- Paid parental leave
- AD&D insurance
Director, Supplier Quality
Revelyst —Irvine, CA
- $200,000 - $220,000 a year
- Full-time
- Engineering
- Master's degree
- Product management
- Paid holidays
- Disability insurance
Director of Quality, Space
Karman Space & Defense —Corona, CA
- $140,000 - $180,000 a year
- Full-time
- Up to 50% travel
- Engineering
- Travel
Director of QA
CTK USA INC —Corona, CA
- From $170,000 a year
- Full-time
- English
- Master's degree
- Analysis skills
- Paid holidays
- Health insurance
Quick Apply
2d
Director of Quality and Patient Safety (Lakewood/Los Alamitos) - FT Days
University of California, Irvine —Orange, CA
- $154,200 - $306,600 a year
- Full-time
- Background check
- Management
- 5 years
- Health insurance
- Retirement plan
Director of Quality Assurance
LeFiell Manufacturing Company —Santa Fe Springs, CA
- $135,000 - $145,000 a year
- Full-time
- Background check
- Bachelor of Science
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Director of Quality
KPC GLOBAL MEDICAL CENTERS INC. —Santa Ana, CA
- $74.03 - $90.48 an hour
- Full-time
- Nursing
- Management
- RN License
- AD&D insurance
- Paid time off
Quick Apply
Director of Quality and Patient Safety (Orange/Irvine) - FT Days
University of California, Irvine —Orange, CA
- $149,700 - $297,700 a year
- Full-time
- Background check
- 5 years
- Bachelor's degree
- Health insurance
- Retirement plan
Associate Director, Quality Control Laboratory
AbbVie —Irvine, CA
- $141,500 - $268,500 a year
- Full-time
- Bachelor of Science
- 8 years
- Bachelor's degree
- Paid holidays
- Health insurance
Pharmaceutical QA Director
Eliquent Life Sciences, Inc —Tustin, CA
- $100 - $150 an hour
- Master's degree
- Bachelor's degree
- Doctor of Philosophy
Quick Apply
5d
Director of Quality
CIRCOR Aerospace Inc —Corona, CA
- Bachelor of Science
- Engineering
- Analysis skills
Quick Apply
Director of Quality and Compliance
Elevate Home Health —Aliso Viejo, CA
- $140,000 - $160,000 a year
- Full-time
- Nursing
- RN License
- 5 years
- Mileage reimbursement
- Disability insurance
Quick Apply
6d
Director, Client Quality Programs
Avid Bioservices —Tustin, CA
- $165,600 - $200,700 a year
- Overtime
- Bachelor of Science
- Basic math
- Conflict management
- Health insurance
- Dental insurance
Quick Apply
Director, Quality Assurance Operations
Avid Bioservices —Tustin, CA
- $165,600 - $207,000 a year
- Overtime
- Microsoft Outlook
- Bachelor of Science
- Basic math
- Health insurance
- Dental insurance
Quick Apply
Director, R&D Quality Assurance
Alcon —Lake Forest, CA
- $183,600 - $237,600 a year
- Full-time
- Doctoral degree
- Surgery
- High school
- Health insurance
Director of Quality Assurance - PCB Manufacturing
Pioneer Circuits Inc. —Santa Ana, CA
- $150,000 - $190,000 a year
- Full-time
- Engineering
- Research
- Analysis skills
- Paid holidays
- Health insurance
Quick Apply
Director, Quality (Clinical Laboratory)
Quest Diagnostics —San Juan Capistrano, CA
- $175,000 - $210,000 a year
- Full-time
- Writing skills
- 3 years
- Master's degree
- Employee stock purchase plan
- Disability insurance
Quick Apply
Director, QA Operations (Quality Events and Data Analytics)
Avid Bioservices —Tustin, CA
- $165,600 - $207,000 a year
- Overtime
- Bachelor of Science
- Basic math
- 3 years
- Health insurance
- Dental insurance
Quick Apply
Sr. Director, Quality Assurance Operations
Avid Bioservices —Costa Mesa, CA
- $195,200 - $244,000 a year
- Overtime
- Bachelor's degree
- Senior level
- Ability to lift 25 pounds
- Health insurance
- Dental insurance
Quick Apply
Director, Quality Control Analytical Sciences and Technology
Avid Bioservices —Tustin, CA
- $163,000 - $204,000 a year
- Overtime
- Bachelor of Science
- Writing skills
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
12d

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Director, Quality Systems

Masimo -
Irvine, CA

Apply Now

Job Details

Full-time
$170,000 - $210,000 a year

Benefits

Paid parental leave
AD&D insurance
Paid holidays
Disability insurance
Health insurance
On-site gym
Dental insurance
401(k)
Flexible spending account
Parental leave
Employee assistance program
Vision insurance
Pet insurance

Qualifications

Compliance risk assessment
Accreditation standards (regulatory compliance area)
Schematics
ISO standards
Computer literacy
Preventive action implementation
Interpreting technical drawings
Production deviation management
Quality control preventive actions
Corrective and preventive actions (CAPA)
English
Incident Escalation
Trend analysis
Quality risk management
Quality control data analysis
Medical device manufacturing facility experience
Data analytics
Leading team collaboration initiatives
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Managing projects
Technical project management
Process improvement planning
Hazard analysis
Managing product quality assurance teams
Escalation handling
Cross-functional team management
General management
Cross-functional communication
FDA regulations

Full 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.

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.

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.

Apply Now

Refine Your Search

director of quality jobs in orange county ca

Director, Quality Systems

Director, Supplier Quality

Director of Quality, Space

Director of QA

Director of Quality and Patient Safety (Lakewood/Los Alamitos) - FT Days

Director of Quality Assurance

Director of Quality

Director of Quality and Patient Safety (Orange/Irvine) - FT Days

Associate Director, Quality Control Laboratory

Pharmaceutical QA Director

Director of Quality

Director of Quality and Compliance

Director, Client Quality Programs

Director, Quality Assurance Operations

Director, R&D Quality Assurance

Director of Quality Assurance - PCB Manufacturing

Director, Quality (Clinical Laboratory)

Director, QA Operations (Quality Events and Data Analytics)

Sr. Director, Quality Assurance Operations

Director, Quality Control Analytical Sciences and Technology

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