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Director Quality Engineering Jobs in California (NOW HIRING)

Senior Quality Engineer

Pleasanton, CA · On-site

$98K - $133K/yr

... Engineering leadership across new product development (NPD), sustaining product changes, and ... This position reports to the Director, Quality . This is a full-time, hybrid position that is ...

Director Quality

Ontario, CA · On-site

$165K - $210K/yr

SUMMARY We are looking for an experienced Director of Quality, to join our Brightline West team ... REQUIRED AND PREFERRED EXPERIENCE * BS Civil Engineering, Building Construction, Construction ...

Director Quality Assurance This position is based in our Campbell, California offices. This ... Bachelor's degree in engineering or related discipline and a minimum of 10 years of progressive ...

Senior Quality Engineer

Pleasanton, CA

$98K - $133K/yr

... Engineering leadership across new product development (NPD), sustaining product changes, and ... This position reports to the Director, Quality . This is a full-time, hybrid position that is ...

Bachelor's or foreign equivalent degree in Manufacturing Engineering, Electrical or Electronic Engineering, Quality Management, or closely related field * 5 years of progressive experience in ...

Director - Quality

Oceanside, CA · On-site

$169K - $180K/yr

Bachelor's or foreign equivalent degree in Manufacturing Engineering, Electrical or Electronic Engineering, Quality Management, or closely related field * 5 years of progressive experience in ...

Director - Quality

Oceanside, CA · On-site

$170 - $180/hr

Bachelor's or foreign equivalent degree in Manufacturing Engineering, Electrical or Electronic Engineering, Quality Management, or closely related field * 5 years of progressive experience in ...

The Quality Engineering Manager will support Cevians 3 operating sites quality engineers. Will ... Provide continuous leadership, training and coaching to direct report and across the organization

Quality Engineering, Manager

Marina, CA · On-site

$170K - $267K/yr

Minimum 3 years of direct people management experience. * Strong understanding of mechanical ... ASQ Certified Quality Engineer (CQE). * ASQ Certified Manager of Quality/Organizational Excellence ...

Minimum 3 years of direct people management experience. * Strong understanding of mechanical ... ASQ Certified Quality Engineer (CQE). * ASQ Certified Manager of Quality/Organizational Excellence ...

Quality Engineering, Manager

Marina, CA · On-site

$170K - $267K/yr

Minimum 3 years of direct people management experience. * Strong understanding of mechanical ... ASQ Certified Quality Engineer (CQE). * ASQ Certified Manager of Quality/Organizational Excellence ...

Quality Engineering, Manager

Marina, CA · On-site

$170K - $267K/yr

Minimum 3 years of direct people management experience. * Strong understanding of mechanical ... ASQ Certified Quality Engineer (CQE). * ASQ Certified Manager of Quality/Organizational Excellence ...

Quality Engineering, Manager

San Carlos, CA · On-site

$170.50 - $267.40/hr

Minimum 3 years of direct people management experience. * Strong understanding of mechanical ... ASQ Certified Quality Engineer (CQE). * ASQ Certified Manager of Quality/Organizational Excellence ...

Showing results 21-40

Director Quality Engineering information

See California salary details

$30.6K

$124K

$210.7K

How much do director quality engineering jobs pay per year?

As of Sep 2, 2026, the average yearly pay for director quality engineering in California is $123,956.00, according to ZipRecruiter salary data. Most workers in this role earn between $89,800.00 and $149,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a director quality engineering?

To thrive as a Director of Quality Engineering, you need a strong background in quality assurance methodologies, leadership experience, and a relevant degree such as engineering or computer science. Familiarity with tools like Selenium, Jenkins, Jira, and knowledge of ISO or Six Sigma certifications are typically expected. Exceptional communication, strategic thinking, and team management skills help drive quality initiatives and foster a culture of continuous improvement. These skills are essential for ensuring product excellence, regulatory compliance, and operational efficiency within the organization.

How does a director quality engineering typically collaborate with cross-functional teams to drive quality initiatives?

A Director of Quality Engineering works closely with product management, development, operations, and customer support teams to ensure quality standards are embedded throughout the product lifecycle. This role often leads quality strategy discussions, sets up cross-team quality metrics, and facilitates regular meetings to address potential quality risks. Effective collaboration involves aligning testing processes with release schedules and ensuring feedback loops between engineering and quality assurance. Building strong partnerships across departments is crucial for proactively identifying issues and implementing continuous improvement initiatives.

What is the difference between Director Quality Engineering vs Quality Manager?

AspectDirector Quality EngineeringQuality Manager
ResponsibilitiesOversees quality engineering teams, develops quality strategies, and ensures product quality at a strategic level.Manages daily quality operations, implements quality control processes, and supervises quality staff.
Required CredentialsBachelor's or Master's in Engineering, Quality Management certifications (e.g., CQE), extensive industry experience.Bachelor's in related field, quality certifications (e.g., CQE, Six Sigma), relevant experience.
Work EnvironmentStrategic planning, cross-department collaboration, leadership roles in engineering teams.Operational focus, hands-on quality inspections, process implementation.

The main difference is that the Director of Quality Engineering focuses on strategic leadership and long-term quality initiatives, while the Quality Manager handles daily quality operations and process management. Both roles require similar credentials but differ in scope and focus within the quality management hierarchy.

What are popular job titles related to Director Quality Engineering jobs in California?

For Director Quality Engineering jobs in California, the most frequently searched job titles are:

What job categories do people searching Director Quality Engineering jobs in California look for?

The top searched job categories for Director Quality Engineering jobs in California are:

What cities in California are hiring for Director Quality Engineering jobs?

Cities in California with the most Director Quality Engineering job openings:

Infographic showing various Director Quality Engineering job openings in California as of August 2026, with employment types broken down into 100% Full Time. Highlights an 85% In-person, 5% Hybrid, and 10% Remote job distribution, with an average salary of $123,956 per year, or $59.6 per hour.

Senior Manager, Quality Engineering

BiVACOR Inc

Huntington Beach, CA • On-site

$158K - $169K/yr

Full-time

Re-posted 7 days ago


Job description

Help Us Build the Future of the Human Heart.
At BiVACOR, we're developing the world's most advanced total artificial heart, a technology capable of saving millions of lives around the world. We're a team united by purpose, working on something truly unprecedented. Every process you validate, every fixture you design, and every challenge you overcome plays a direct role in giving patients a second chance at life. If that's the kind of work that gets you out of bed in the morning, we'd love to meet you.
About the Role
This is a high-impact leadership role at the intersection of quality engineering strategy and clinical-stage medical device development. As Senior Manager, Quality Engineering, you will serve as a principal leader within the BiVACOR quality organization, responsible for architecting and directing quality engineering functions across the full product lifecycle of the Total Artificial Heart (TAH) system, one of the most technically advanced implantable devices in development today.
This elevated role demands a visionary, technically authoritative, and operationally excellent leader with deep expertise in electrical engineering and a distinguished track record with Class III Active Implantable Medical Devices (AIMD). You will not only lead the QE team in verification and validation, manufacturing process quality, supplier controls, and regulatory compliance - you will define the strategic direction of quality engineering programs, drive enterprise-level QMS maturity, and serve as a senior executive liaison across quality, engineering, manufacturing, regulatory affairs, and clinical functions.
You will mentor and grow quality engineering talent, shape organizational quality culture, and partner with senior leadership to advance BiVACOR's mission of bringing a life-saving total artificial heart to patients.
Key Responsibilities
Quality System Leadership & Strategy
  • Define and execute the strategic vision for the QMS, aligned with ISO 13485, 21 CFR Part 820, 803, and 806
  • Serve as the senior quality engineering authority for BSI surveillance audits and FDA inspections
  • Lead and develop a high-performing quality engineering team, providing strategic direction and career development
  • Establish enterprise-wide quality KPIs and present strategic recommendations to executive leadership

Verification, Validation & Design Assurance
  • Direct V&V planning, execution, and documentation for electrical, software, and system-level protocols supporting IDE and PMA submissions
  • Approve test protocols and reports, ensuring traceability to design inputs and applicable standards (ISO 14708, IEC 60601, ISO 14971)
  • Oversee test method validation (TMV) and equipment qualification (IQ/OQ/PQ) programs

Manufacturing Quality & Nonconformance
  • Architect and enforce IPC-A-610 workmanship standards for electronic assemblies across the TAH system
  • Own the nonconformance (NC) and QCIR programs, including MRB disposition, root cause investigation, and CAPA linkage
  • Drive systemic resolution of manufacturing quality escapes with root cause rigor

Risk Management & CAPA
  • Lead FMEA, FTA, and risk management file strategy at the program level per ISO 14971
  • Own and govern the enterprise CAPA process from initiation through effectiveness verification
  • Evaluate field performance data and clinical feedback to identify and mitigate systemic quality risks

Supplier Quality
  • Architect and lead the end-to-end supplier quality program: qualification, performance monitoring, audits, and corrective actions
  • Conduct strategic on-site audits with focus on high-risk and sole-source AIMD-critical suppliers
  • Partner with engineering and procurement to assess supply chain risk and maintain the approved supplier list (ASL)

Cross-Functional & Regulatory Leadership
  • Serve as the senior quality engineering representative in executive program reviews and manufacturing readiness assessments
  • Lead quality engineering strategy for IDE supplements, PMA modules, and FDA information requests
  • Influence and align R&D, Regulatory Affairs, Software, and Manufacturing Engineering on quality strategy throughout the product lifecycle

Continuous Improvement
  • Define and lead the organizational continuous improvement strategy using Lean, Six Sigma, or equivalent methodologies
  • Sponsor initiatives to reduce defect rates, improve first-pass yield, and optimize QMS processes
  • Present improvement initiative outcomes and strategic impact to executive leadership

What You Bring
  • Bachelor's degree or higher in Electrical Engineering (mandatory)
  • Minimum 18 years of experience in the medical device industry, including demonstrated senior quality engineering leadership
  • Direct experience with Class III Active Implantable Medical Devices (AIMD), including deep knowledge of FDA IDE/PMA regulatory requirements
  • IPC-A-610 and/or IPC-A-620 certification strongly preferred

Technical Expertise
  • Expert knowledge of IEC 60601 series, ISO 14971, ISO 13485, and 21 CFR Part 820, 803, and 806
  • Deep experience with electrical and electromechanical system qualification for implantable devices
  • Proficiency in FMEA, FTA, statistical analysis, MSA/Gage R&R, and reliability methodology
  • Experience with EO sterilization qualification, cleanroom operations, and QMS software platforms

Leadership & Influence
  • Proven track record of building and inspiring senior quality engineering teams
  • Demonstrated ability to influence executive stakeholders and drive enterprise-level quality strategy
  • Experience representing quality at a senior level in FDA or notified body inspections
  • Track record of leading cross-functional V&V programs for complex regulatory submissions

Highly Desirable
  • VAD or Total Artificial Heart experience
  • ASQ certification (CQE, CQM/OE, or CRE)
  • Familiarity with Enlil, Arena, or comparable QMS/PLM platforms
  • Experience with IDE clinical studies and associated quality system requirements

The expected salary range for this position based in Huntington Beach California is $155,000 - $169,990. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting
Apply today and be part of something extraordinary.
BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.