Top 628 Quality assurance managers Jobs in Campbell, Ca

Manager, Quality Assurance
Triple Ring Technologies —Fremont, CA
- $125,000 - $150,000 a year
- Hybrid work
- Bachelor of Science
- Bachelor's degree
- Software development
- Paid holidays
- Health insurance
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4d
Quality Assurance Specialist
Noah Medical —San Jose, CA
- $75,000 - $94,000 a year
- Hybrid work
- Surgery
- Mid-level
- Analysis skills
- Paid parental leave
- Health savings account
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10d
Quality Assurance Engineering Manager
RapidFort, Inc. —Sunnyvale, CA
- $165,000 - $200,000 a year
- Full-time
- Computer science
- Azure
- Computer Science
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Lead Quality Assurance Inspector
ABSOLUTE TURNKEY SERVICES INC —Santa Clara, CA
- $25 - $40 an hour
- Overtime
- Computer literacy
- Writing skills
- English
- Profit sharing
- Paid holidays
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Manager, Quality Assurance
THINK Surgical, Inc. —Fremont, CA
- $165,000 - $180,000 a year
- Weekends as needed
- Engineering
- Office
- 3 years
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Quality Assurance Manager
Hayward Quartz Technology, Inc. —Fremont, CA
- Senior level
Assistant Program Director
CAMINAR —Redwood City, CA
- $77,000 - $80,000 a year
- Full-time
- Experience working with individuals with disabilities
- Ability to walk for extended periods
- Computer literacy
- Wellness program
- Commuter assistance
5d
Shelter Program Manager - Family Shelter Services
BILL WILSON CENTER —Sunnyvale, CA
- $70,304 - $75,000 a year
- Weekends as needed
- Background check
- Spanish
- CPR Certification
- Paid holidays
- Health insurance
Radiation Therapist II, $10K Sign-On Bonus
Stanford Health Care —Palo Alto, CA
- $70.52 - $93.43 an hour
- 8 hour shift
- Anatomy knowledge
- Patient monitoring
- BLS Certification
- Health savings account
- Health insurance
Senior Case Manager
Community Services Agency —Mountain View, CA
- $30.20 - $31.25 an hour
- Full-time
- Background check
- Spanish
- Experience working with individuals with disabilities
- Health insurance
- Dental insurance
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Licensed Psychotherapist (Pediatric IOP/PHP) - Floor Manager
LGTC Group —San Jose, CA
- From $80,000 a year
- Full-time
- LMFT
- Licensed Clinical Social Worker
- Outpatient experience
- Dental insurance
- 401(k)
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Radiation Therapist II, $10K Sign-On Bonus
Stanford Health Care —Palo Alto, CA
- $70.52 - $93.43 an hour
- 8 hour shift
- Anatomy knowledge
- Patient monitoring
- BLS Certification
- Health savings account
- Health insurance
Radiologic Technologist
UCSF Health | GoHealth Urgent Care —Redwood City, CA
- $43 - $55 an hour
- Full-time
- Anatomy knowledge
- BLS Certification
- Urgent Care
- Health insurance
- Dental insurance
Quick Apply
Federal Tax Manager - Global Compliance and Reporting - SAN JOSE / San Francisco
EY —San Jose, CA
- $103,600 - $215,800 a year
- CPA
- 5 years
- Analysis skills
- Paid holidays
- Health insurance
Federal Tax Manager - Global Compliance and Reporting - SAN JOSE / San Francisco
EY —San Jose, CA
- $103,600 - $215,800 a year
- CPA
- 5 years
- Analysis skills
- Paid holidays
- Health insurance
Open Box Assurance (OBA) Supervisor
Quanta Manufacturing Fremont —Fremont, CA
- $72,000 - $90,000 a year
- Full-time
- Spanish
- 5 years
- English
- Health insurance
- Dental insurance
Quick Apply
Perfusionist II
Stanford Health Care —Palo Alto, CA
- $100.65 - $113.34 an hour
- Full-time
- Surgery
- Current TB test
- BLS Certification
- Health savings account
- Health insurance
Service Delivery Manager (Bilingual Required - Eng/Span) - MultiPro Property Solutions
Valet Living LLC —San Jose, CA
- $70,500 - $75,000 a year
- Online Application
- Spanish
- Construction site
- English
- Health savings account
- AD&D insurance
Quick Apply
10d
Traveling Lead Installation Technician
C&C Installations —San Jose, CA
- $22 - $28 an hour
- Full-time
- Customer service
- Mid-level
- Ability to lift 50 pounds
Quick Apply
General Manager
King's Fish House - San Jose —San Jose, CA
- $110,000 - $130,000 a year
- Weekends as needed
- Bar
- 21 years or older
- Quality control
- Health savings account
- Health insurance
Quick Apply

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Manager, Quality Assurance

Triple Ring Technologies -
Fremont, CA

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Job Details

$125,000 - $150,000 a year
4 days ago

Benefits

Paid holidays
Health insurance
Dental insurance
Vision insurance
401(k) matching

Qualifications

FDA submissions
Regulatory inspections
Managing medical device teams
Clinical research
Medical device testing
AI tools proficiency
ISO certification audits
Quality control audit
Software quality assurance team management
Managing engineering teams
Quality risk management
Regulatory readiness in healthcare
Design controls
Biomedical regulatory compliance
Regulatory submissions
Productivity software
Manufacturing
Project leadership
Audit support

Full Job Description

Triple Ring Technologies, Inc. offers a unique environment for talented individuals interested in undertaking varied technical challenges, primarily in medical device and life science industries. Headquartered in Newark, CA, we are an innovative research and development company that partners with clients to deliver complex technical solutions. Our highly interdisciplinary team includes senior professionals from industry, finance, and academia, with extensive experience in medical device, life science, clean tech, security, and industrial technologies. We rely upon each other for technical excellence, real-world engineering and commercial wisdom. Learn more at www.tripleringtech.com.

Job Summary

The Manager of Quality Assurance will maintain and lead the implementation of Triple Ring's Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the QMS elements of a project. These will include all applicable QMS deliverables related to product planning, design and development of hardware, software, and AI/ML-enabled systems, engineering builds, clinical builds, and transfer to manufacturing.

Responsibilities

Provide project teams with the guidance necessary to maintain a high level of ISO13485:2016 QMS compliance, with specific focus on hardware, software and system design assurance activities.
Ensure that medical device design project quality planning is consistent with project objectives and delivers a Quality Management Responsibilities Plan for individual projects as needed
Ensure that medical device design project quality activities are efficient and effective and performed in a proactive manner
Oversee the generation and maintenance of quality records that are consistent with Triple Ring's QMS
Ensure that quality records are maintained in a state of readiness for external audits and regulatory inspections
Maintain and regularly update Triple Ring's library of applicable technical, quality, and risk management standards
Maintain Triple Ring's ISO13485:2016 certification, including managing and conducting internal audits
Develop SOPs, work instructions, guidance documents and templates to drive compliance and to facilitate dissemination of best practices related to ISO13485:2016 quality management systems
Support and manage ISO13485:2016QMS related training and professional development for Triple Ring scientific and technical staff
Own the Management Review process, managing and reporting project and operational quality metrics to management
Provide input to quality-related planning to meet short and long term business goals
Provide management with objective evaluation of overall quality performance and guidance for implementation of improvements
Actively participate in developing and deploying effective continuous improvement of Triple Ring's quality management processes
Serve as the ISO13485:2016 QMS Management Representative, interfacing with the ISO Registrar and with Regulatory Agencies as necessary
Manage Triple Ring's Document Control function and related personnel

Education, Experience, and Skills

Expert in medical device design assurance activities, including design controls, risk management, software development lifecycle, design reviews, design transfer and medical device regulatory submissions.
Demonstrated hands-on experience personally executing and reviewing design assurance deliverables—design controls, Design History File (DHF) and requirements traceability, risk management, and verification and validation (V&V)—for hardware, software, and AI/ML-enabled medical devices; this is a hands-on technical role, not an oversight- or audit-only function.
Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced degree preferred
ISO 13485 – Lead Assessor Certification required. Other ASQ and RAPS Certifications are a plus (e.g., Certfifed Quality Auditor, Certified Quality Engineer, Certified Quality Manager-Operational Excellence)
Experience hosting external audits and regulatory inspection as primary audit guide a must.
Strong understanding and application of the following medical device standards is required.
- ISO 13485:2016,
- ISO14971:2019,
- ISO/IEC62304:2006,
- IEC60601-1/IEC61010
In-depth knowledge of current regulatory expectations, quality and compliance processes, operations and strategy related to medical device development lifecycle, from ideation to commercial distribution.
Previous experience collaborating with medical device submission, such as US FDA 510(K) and PMA is required.
Demonstrated knowledge of interpretation and application of 21CFR820 QMSR. Understanding of EU-MDR and other MDSAP OUS regions a plus.
Working understanding of GCP clinical investigation and validation activities.
Minimum three (3) years of active medical device quality engineering or design assurance background, with additional 2 years of quality leadership experience;
Strong Experience in design, manufacturing, process validation for medical devices or other technically complex or regulated products
Working knowledge of engineering design and build practices
Working knowledge of basic assembly and manufacturing processes
Progressive QA/QC leadership experience, including "hands-on" detailed quality systems development and experience managing implementation of quality functions and related personnel
Demonstrated leadership of design assurance across concurrent hardware, software, and AI/ML workstreams within a single device program, including setting strategy and reviewing deliverables produced by project engineers
Experience implementing electronic Quality Management System (eQMS) and other relevant computer system validation (CSV) /computer system assurance (CSA) activities.
Comfortable with electronic documentation/records systems (e.g., Windchill, Helix) and strong general office computing skills, including experience with creating Microsoft Office templates and using AI Tools.

Desired skills:

Hands-on experience standing up or maturing design assurance for AI/ML-enabled SaMD, including dataset and data-provenance controls, model verification and validation, and ongoing algorithm performance monitoring
Experience defining and executing software and algorithm verification and validation (V&V) strategy traceable to design inputs, hazard analysis, and risk controls, including IEC 62304 software safety classification
IEC 81001-5-1 (health software security) and AI/ML governance frameworks—FDA Good Machine Learning Practice (GMLP), AAMI CR34971/TR34971, and ISO/IEC 42001—a plus
Previous direct medical device submission responsibility as primary sponsor is a plus

Our benefit program includes: flexible time off, paid holidays, 401(k) plan with employer match, bonus, equity, a variety of medical, dental and vision plan options, and more.

The annual salary range for jobs which are performed in US, California is $125,000 to $150,000. Please note that the salary range is a guideline and compensation may vary based on factors such as qualifications, skill level, experience, competencies and work location.

This role will be eligible for our hybrid work model which requires working onsite a minimum of 3 days per week: Tuesday, Wednesday, and 1-day of your choice. In certain circumstances the hybrid work model may change to accommodate business needs.

Triple Ring Technologies is an Equal Employment Opportunity Employer and is committed to workforce diversity, providing equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.

Triple Ring Technologies complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, please email [email protected].

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Refine Your Search

quality assurance managers jobs in campbell, ca

Manager, Quality Assurance

Quality Assurance Specialist

Quality Assurance Engineering Manager

Lead Quality Assurance Inspector

Manager, Quality Assurance

Quality Assurance Manager

Assistant Program Director

Shelter Program Manager - Family Shelter Services

Radiation Therapist II, $10K Sign-On Bonus

Senior Case Manager

Licensed Psychotherapist (Pediatric IOP/PHP) - Floor Manager

Radiation Therapist II, $10K Sign-On Bonus

Radiologic Technologist

Federal Tax Manager - Global Compliance and Reporting - SAN JOSE / San Francisco

Federal Tax Manager - Global Compliance and Reporting - SAN JOSE / San Francisco

Open Box Assurance (OBA) Supervisor

Perfusionist II

Service Delivery Manager (Bilingual Required - Eng/Span) - MultiPro Property Solutions

Traveling Lead Installation Technician

General Manager

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