Top 1118 Quality systems specialist Jobs in San Francisco, Ca

Senior Quality System Specialist (Temporary)
Neptune Medical —Burlingame, CA
- $57.50 - $72.00 an hour
- Temporary
- 7 years
- Engineering
- Data analysis skills
Technical Support Specialist
Anrok —San Francisco, CA
- $80,000 - $100,000 a year
- Full-time
- Hybrid work
- Mid-level
- Office
- Communication skills
- Health insurance
- Dental insurance
Grants & Compliance Analyst– Head Start
JBS International —San Mateo, CA
- Full-time
- Remote
- Mid-level
- Residential
- Ability to lift 50 pounds
Quick Apply
Research Associate
Pendulum™ —San Francisco, CA
- $89,000 - $99,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Commuter assistance
- Disability insurance
Quick Apply
10d
Risk Operations Specialist, Payments
Ramp —San Francisco, CA
- $100,000 - $184,000 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Mid-level
- SQL
- Travel reimbursement
- AD&D insurance
Program Analyst (Public Records Specialist)
The State Bar of California —San Francisco, CA
- $92,960 - $123,943 a year
- Full-time
- Hybrid work
- Word processing
- Writing skills
- Mid-level
Quick Apply
Specialist II, BioAnalytical Systems Analyst
Corcept Therapeutics —Redwood City, CA
- $101,300 - $119,200 a year
- Microsoft Excel
- Microsoft Outlook
- Mid-level
Quick Apply
2d
Production Specialist
Hearst Media Services —San Francisco, CA
- $66,000 - $70,000 a year
- Full-time
- Hybrid work
- Mid-level
- 2 years
- Health insurance
- Dental insurance
10d
CSV Specialist
Katalyst Healthcares & Life Sciences —San Francisco, CA
- Contract
- 5 years
- Engineering
- English
Quick Apply
ECM Data Coordinator
San Francisco Community Health Center —San Francisco, CA
- $35 - $40 an hour
- Full-time
- Bilingual
- HIPAA
- Mid-level
Quick Apply
Bioprocess Specialist - CONTRACT
GeneFab —Alameda, CA
- $40 - $50 an hour
- Weekends as needed
- Mid-level
- High school diploma or GED
- Team management
Quick Apply
Payment Systems Specialist II
SF Fire Credit Union —San Francisco, CA
- $33.10 - $49.64 an hour
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
- Wellness program
- Paid holidays
Quick Apply
Health Information Technology Specialist West
IQVIA —San Francisco, CA
- $125,000 - $135,000 a year
- Full-time
- System design
- Mid-level
- Master's degree
AP/AR Specialist
Kikoff —San Francisco, CA
- $85,000 - $95,000 a year
- Hybrid work
- Mid-level
- Office
- Analysis skills
Program Specialist - San Francisco Human Services Agency (2913) (X00129)
City and County of San Francisco —San Francisco, CA
- $105,612 - $128,362 a year
- Online Application
- Hybrid work
- Microsoft Excel
- English
- Research
- Continuing education credits
2d
Medical Events Group Specialist I (Operations)
Abbott Laboratories —Alameda, CA
- $81,500 - $141,300 a year
- Full-time
- Office
- Bachelor's degree
- 1 year
- Health insurance
- Tuition reimbursement
People Success Specialist
Ivo Inc. —San Francisco, CA
- $100,000 - $120,000 a year
- Full-time
- Hybrid work
- Mid-level
- Office
- Continuous improvement
- Commuter assistance
- Health savings account
Quick Apply
Sr. Regulatory Document Formatting Specialist
Vaxcyte —San Carlos, CA
- $112,000 - $131,000 a year
- Microsoft Excel
- 5 years
- Bachelor of Science
Benefit Technology Specialist
HUB International —San Francisco, CA
- Online Application
- Microsoft Excel
- Writing skills
- HIPAA
- Health savings account
- Disability insurance
Specialist, Clinical Supply Chain
Allogene Therapeutics —South San Francisco, CA
- $105,000 - $125,000 a year
- Full-time
- Remote
- Mid-level
- 3 years
- Bachelor's degree
- Health insurance
Quick Apply

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Senior Quality System Specialist (Temporary)

Neptune Medical -
Burlingame, CA

Apply Now

Job Details

Temporary
$57.50 - $72.00 an hour

Qualifications

ISO standards
Biomedical regulatory compliance
Document viewing software
Productivity software
Quality audits
FDA regulations
Customer complaint resolution

Full Job Description

Neptune Medical is a venture backed medical device company based in Silicon Valley. We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization™ technology. Pathfinder® is our first FDA-cleared commercial device incorporating this novel technology. This advanced endoscopy device is being used at a growing list of leading U.S. hospitals and academic medical centers. Now, the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.

POSITION SUMMARY:

The Senior Quality System Specialist ensures the integrity and compliance of the Quality Management System (QMS) for medical devices, with a focus on document control, calibration, equipment control, audits, and training. This role supports regulatory compliance (FDA, ISO 13485, EU MDR), drives continuous improvement, and collaborates with cross-functional teams to maintain high-quality standards throughout the product lifecycle. This position plays a critical role in managing and overseeing the document control processes and systems, ensuring that all documents are properly controlled, maintained, and accessible to authorized personnel.

The ideal candidate will act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

ROLES AND RESPONSIBILITIES:

Oversee and maintain document control systems, ensuring all quality and regulatory documents (SOPs, Device/Batch Records, MDFs, Design & Development Files, change orders) are current, accurate, and compliant with industry standards (FDA QMSR, ISO 13485, EU MDR).
Support and improve quality system processes, including CAPA management, data integrity, and continuous improvement initiatives (e.g. QMSR Gap Assessment).
Oversee and improve document control procedures, including revision/version control, document tracking, and secure archiving.
Oversee Complaints Handling system. Lead monthly complaint meeting.
Manage the Neptune Medical Approved Supplier List, including annual review.
Provide Management Review input. Own approval of Management Review output.
Participate in Process Nonconformance (PNRs) and Material Nonconformance (MRRs) review, as required.
Own CAPAs, as required.
Manage post market surveillance activities in the applicable jurisdictions (USA & EU). Author applicable reports.
Incorporate new and updated external documents (e.g., regulations, standards, guidance) into the Neptune Medical QMS. Perform an annual audit of the External Documents List.
Coordinate and maintain calibration programs for inspection, measurement, and test equipment, ensuring timely calibration and proper documentation.
Oversee equipment control, including preventive maintenance schedules, equipment ID assignment, and equipment history file maintenance.
Develop, deliver, and track quality system training for staff to ensure understanding and adherence to QMS requirements.
Ensure training plans are established for Neptune Medical employees.
Update/assign training plans in eQMS.
Train new hires on eQMS software and training program.
Plan, conduct, and support internal and external audits; coordinate audit responses and corrective actions to ensure ongoing compliance with regulatory standards (FDA QMSR, ISO 13485, EU MDR)
Interact with regulatory bodies and auditors during inspections, providing documentation and ensuring readiness for audits.
Represent areas of responsibility in the front room of both internal and external quality audits.
Interact with regulatory bodies and auditors during inspections, providing documentation and ensuring readiness for audits.
Represent areas of responsibility in internal and external quality audits.
Perform analysis for Quality metrics, Management Review, etc.
Work in accordance with quality system procedures.

REQUIRED QUALIFICATIONS:

Bachelor’s degree in Science, Engineering, or a related field.
Minimum 7 years of experience in quality assurance or quality systems within the medical device industry, with hands-on experience in document control, equipment management, and audits.
Experience using an electronic quality management system, e.g., Arena, EtQ. Experience using Propel is preferred.
Understanding of 21 CFR 820 and ISO 13485 quality system requirements.
Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint) and PDF software.
Be results-oriented with appropriate urgency.
Good organizational, oral and written communication skills.
Willingness to work in a startup environment and adapt to changing needs and priorities.
Eagerness to learn new things.

Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station

Our job titles may span more than one career level. The starting base pay for this role is between $57.50 and $72.00 per hour depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This will initially be a temporary role, with the possibility of being made permanent at the end of the year.

Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Apply Now

Refine Your Search

quality systems specialist jobs in san francisco, ca

Senior Quality System Specialist (Temporary)

Technical Support Specialist

Grants & Compliance Analyst– Head Start

Research Associate

Risk Operations Specialist, Payments

Program Analyst (Public Records Specialist)

Specialist II, BioAnalytical Systems Analyst

Production Specialist

CSV Specialist

ECM Data Coordinator

Bioprocess Specialist - CONTRACT

Payment Systems Specialist II

Health Information Technology Specialist West

AP/AR Specialist

Program Specialist - San Francisco Human Services Agency (2913) (X00129)

Medical Events Group Specialist I (Operations)

People Success Specialist

Sr. Regulatory Document Formatting Specialist

Benefit Technology Specialist

Specialist, Clinical Supply Chain

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