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Project Manager Quality Systems Jobs in San Ramon, CA

Mercor

Program Manager, Quality

San Francisco, CA · On-site

$120K - $200K/yr

... the systems that are redefining society. Mercor is a profitable Series C company valued at $10 ... Own outcomes end to end for quality programs on projects: from initial brainstorming and ...

CYNET SYSTEMS

Sr. Project Manager

Sunnyvale, CA · On-site

$95 - $100/hr

Ensure compliance to internal business and quality system requirements and external regulatory ... Project Management. * Agile. * Logistics. * Transportation Management. * Warehouse Management.

Microchip

Manager - Quality Engineering

San Jose, CA · On-site

Site quality systems development and continual improvement, working within the site teams to maintain ISO9001, AS9100 certifications and other industry standards * Site Quality Management Plan to ...

Northrop Grumman

Manager Quality 2

Sunnyvale, CA · On-site

$133K - $199K/yr

... projects, operational decisions, and scheduling customer inspection activities. Maintains compliance with Quality Management System (QMS) policies, procedures, and processes to ensure the performance ...

Pivotal Systems

Quality Manager

Fremont, CA · On-site

Quality Manager Engineering - Fremont, California The Quality Manager is a key leader within Pivotal Systems' quality organization, reporting to the Director of Quality, and plays a central role in ...

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Project Manager Quality Systems information

See San Ramon, CA salary details

$84.4K

$130.7K

How much do project manager quality systems jobs pay per year?

As of Sep 10, 2026, the average yearly pay for project manager quality systems in San Ramon, CA is $130,062.00, according to ZipRecruiter salary data. Most workers in this role earn between $130,200.00 and $130,200.00 per year, depending on experience, location, and employer.

What is a project manager quality systems?

A Project Manager Quality Systems is a professional responsible for overseeing the planning, implementation, and maintenance of quality management systems within an organization. They ensure that processes and deliverables meet regulatory standards and internal quality benchmarks throughout a project's lifecycle. This role often involves coordinating cross-functional teams, developing quality assurance protocols, conducting audits, and driving continuous improvement initiatives. Project Manager Quality Systems play a critical role in industries such as healthcare, manufacturing, and pharmaceuticals, where adherence to quality standards is essential.

How does a project manager quality systems typically collaborate with cross-functional teams to achieve quality objectives?

A Project Manager Quality Systems works closely with cross-functional teams, including engineering, manufacturing, regulatory, and quality assurance, to ensure that quality standards are integrated into every stage of a project. This often involves leading meetings, facilitating communication between departments, and aligning project goals with compliance requirements. Effective collaboration is key to identifying potential quality risks early and implementing corrective actions promptly. By fostering a culture of quality and continuous improvement, the Project Manager helps teams stay focused on delivering consistent, high-quality results.

What are the key skills and qualifications needed to thrive as a project manager quality systems, and why are they important?

To thrive as a Project Manager Quality Systems, you need strong project management abilities, a solid understanding of quality assurance principles, and typically a relevant degree such as engineering or life sciences. Familiarity with quality management systems (QMS), regulatory compliance standards (like ISO 9001), and project management tools (such as MS Project or Jira) is essential. Outstanding communication, leadership, and problem-solving skills help you drive cross-functional collaboration and continuous improvement. These competencies are vital to ensure projects are delivered efficiently while meeting stringent quality and regulatory requirements.

What is the difference between Project Manager Quality Systems vs Quality Assurance Specialist?

AspectProject Manager Quality SystemsQuality Assurance Specialist
CertificationsISO 9001 Lead Auditor, PMPISO 9001 Lead Auditor, CQE
Work EnvironmentCross-departmental, project-focusedQuality department, compliance-focused
Employer & Industry UsageManufacturing, pharma, techManufacturing, healthcare, biotech

The Project Manager Quality Systems oversees quality projects, ensuring compliance and process improvements across departments. The Quality Assurance Specialist focuses on maintaining quality standards, conducting audits, and ensuring product compliance. While both roles require similar certifications and work within quality frameworks, the project manager emphasizes managing initiatives, whereas the QA specialist concentrates on compliance and testing.

What cities near San Ramon, CA are hiring for Project Manager Quality Systems jobs?

Cities near San Ramon, CA with the most Project Manager Quality Systems job openings:

Infographic showing various Project Manager Quality Systems job openings in San Ramon, CA as of August 2026, with employment types broken down into 1% As Needed, 76% Full Time, 18% Part Time, 4% Contract, and 1% Nights. Highlights an 88% Physical, 2% Hybrid, and 10% Remote job distribution, with an average salary of $130,062 per year, or $62.5 per hour.

Senior Manager, Quality System & Compliance

San Francisco, CA • On-site

Heartflow
Medical Equipment and Supplies Manufacturing • 201 - 500 employees
Learn more about Heartflowexternal

Full-time

Posted 8 days ago

HeartFlow rating

7.2

Company rating: 7.2 out of 10

Based on 11 frontline employees who took The Breakroom Quiz

Job description

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 750,000 patients worldwide.
As the Senior Manager of Quality System and Quality (Regulatory) Compliance, you are a pivotal leader responsible for the strategy, execution, and continuous improvement of our Quality Management System (QMS), oversight, and associated tools. You will lead our efforts to ensure robust compliance with national and international medical device regulations, including FDA, ISO 13485, EU MDR, and MDSAP. This role is a unique blend of strategic foresight and tactical leadership, requiring a deep expertise in QMS setup and management, particularly for Software as a Medical Device (SaMD), with ability to make thoughtful changes and enhance the overall QMS.
You will lead a high-performing team of quality professionals , championing a "Quality-first" culture and driving data-driven decisions. Your proven track record of navigating complex regulatory landscapes, including FDA, PMDA, IEC, EU MDR, and ISO regulations and standards, is essential to our success.
Job Responsibilities:
Quality Management System (QMS) Oversight
  • Manage holistic aspects of the QMS to ensure compliance with global regulations, including FDA, ISO 13485, EU MDR, and MDSAP countries' requirements.
  • Oversee the following key QMS subsystems: CAPA subsystem, Document Control, Training, Management Review, Internal Audits, and External Audit management, QMS Tool Validation, and Supplier Management.
  • Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the QMS.

Quality Compliance & Audits
  • Serve as the front room or backroom lead and the primary subject matter expert (SME) for the QMS during audits, including inspections by the FDA, Notified Bodies, and other regulatory authorities.
  • Prepare the organization for an appropriate level of quality compliance to U.S. and international requirements to support Heartflow's global expansion.

Strategic Leadership & Team Development
  • Lead, mentor, and scale a team of QMS professionals, fostering career growth and technical excellence.
  • Champion a "Quality-first" mindset throughout the organization, through collaboration and using impactful KPIs to drive accountability and data-driven decisions.
  • Collaborate with leaders and partners in R&D, Production, Regulatory, Clinical, and Product Management to integrate quality processes seamlessly, balancing compliance with business objectives.
  • Manage departmental resources, including headcount and long-term strategic planning.
Skills Needed:
  • Effective, clear, and concise communication skills bringing clarity to complex topics across the leadership spectrum.
  • Ability to coach, mentor, and drive a collaborative quality culture through influence.
  • Deep understanding of Quality System and Quality Compliance.
  • Experience interacting with auditors, including Notified Body auditors and FDA Investigators.
Educational Requirements & Work Experience:
  • Bachelor's degree in engineering or scientific discipline, or equivalent.
  • 10+ years of progressive experience in Quality within the medical device industry, with at least 5+ years in a leadership/management role.
  • Expert-level knowledge of relevant regulations and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.
  • Proven track record of successfully leading or playing a key SME role in regulatory inspections (FDA, Notified Body).
  • Exceptional leadership and communication skills, with a demonstrated ability to influence and build consensus among cross-functional senior leaders.

Preferred:
  • Direct experience with AI/ML-driven SaMD and cloud-based medical device platforms.
  • Familiarity with medical device cybersecurity standards (e.g., AAMI TIR57) and data privacy regulations.
  • Experience with global regulatory submissions (e.g., CE Marking, PMDA).
  • Experience implementing and scaling quality processes in a fast-paced and growing environment.

This position has an estimated base salary of $195,000 - $250,000, bonus, and equity. #LI-IB1; LI-Hybrid
Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.
Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.
Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with "@heartflow.com" and B) the position described is found on our careers site at www.heartflow.com/about/careers/.

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