Top 56 Director of quality assurance Jobs in Fremont Ca

Director, Quality Engineering Operations, Disposables & Accessories
PROCEPT BioRobotics Corporation —San Jose, CA
- $220,500 - $259,410 a year
- Full-time
- Bachelor of Science
- 8 years
- Analysis skills
- Opportunities for advancement
Quick Apply
Director, CMC QC Small Molecules
Ultragenyx Pharmaceutical —South San Francisco, CA
- $232,600 - $287,400 a year
- Hybrid work
- 5 years
- Master's degree
- Bachelor's degree
- Gym membership
Director of Quality Assurance
Vital Connect Inc —San Jose, CA
- $200,000 - $230,000 a year
- Management
- 8 years
- Bachelor's degree
- Dental insurance
Quick Apply
Director Quality and Mission Assurance
Honeywell Aerospace —San Jose, CA
- Full-time
- Management
- Senior level
Sr. Director, Quality Assurance for Quality Control
Vaxcyte —San Carlos, CA
- $229,000 - $268,000 a year
- 11+ years
- Bachelor's degree
- Senior level
Head of Quality Assurance
Aspect Biosystems —Fremont, CA
- $191,000 - $202,000 a year
- Master's degree
- Doctor of Philosophy
- Mentoring
Quick Apply
Director, Quality Operations
FM Industries —Fremont, CA
- $162,837 - $211,688 a year
- Full-time
- Computer literacy
- Bachelor of Science
- Office
Sr. Manager / Associate Director, Quality Audits
Personalis, Inc —Fremont, CA
- $165,000 - $210,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- 8 years
- Analysis skills
- Commuter assistance
- Employee stock purchase plan
Director, Quality Assurance Operations
Adicet Bio —Redwood City, CA
- $199,000 - $274,000 a year
- Full-time
- 5 years
- Office
- Bachelor's degree
- Free parking
- Paid parental leave
Director, Operations and Customer Quality Program Engineer
Applied Materials —Santa Clara, CA
- $180,500 - $248,500 a year
- Full-time
- Travel
- Manufacturing
- Senior level
Senior Director / Director - CMC/GMP Quality Assurance
Semnur, Inc. —Palo Alto, CA
- $235,000 - $285,000 a year
- Full-time
- Hybrid work
- Adults
- Office
- Contracts
Quick Apply
Associate Director of QC / HPLC
Asahi Kasei —Fremont, CA
- $155,000 - $200,000 a year
- Full-time
- 6 years
- Bachelor of Science
- Bachelor's degree
- Health insurance
- Dental insurance
Associate Director, Quality Assurance - CMC Operations
Protagonist Therapeutics —Newark, CA
- $175,000 - $225,000 a year
- Full-time
- Office
- Bachelor's degree
- Travel
- Wellness program
- Commuter assistance
Quick Apply
4d
Director Quality Assurance
Imperative Care —Campbell, CA
- $234,000 - $244,000 a year
- Full-time
- Engineering
- Adults
- Office
- Health insurance
- 401(k)
Director, Quality Assurance
insitro —South San Francisco, CA
- $205,000 - $218,000 a year
- Full-time
- Hybrid work
- Computer literacy
- Office
- Computer skills
- Paid parental leave
- Health insurance
Director Supplier Quality
Abbott Laboratories —Pleasanton, CA
- $172,000 - $344,000 a year
- Full-time
- Master's degree
- Bachelor's degree
- Recruiting
- Health insurance
- Tuition reimbursement
1d
Senior Director, Reliability Engineering
NVIDIA —Santa Clara, CA
- $332,000 - $500,250 a year
- Full-time
- Engineering
- Analysis skills
- Math
Sr/Exec Director, Quality Assurance GCP
Erasca —South San Francisco, CA
- $250,000 - $290,000 a year
- Remote
- 11+ years
- Bachelor's degree
- Mentoring
- Health savings account
- AD&D insurance
Associate Director, Quality Assurance Compliance
Gilead Sciences —Foster City, CA
- $165,495 - $235,620 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- 5 years
- Health insurance
- Dental insurance
ASSOCIATE DIRECTOR, AUDIT QUALITY ASSURANCE - HYBRID
University of California Office of the President —Oakland, CA
- $170,000 - $205,000 a year
- Full-time
- Hybrid work
- Background check
- CPA
- 5 years

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Director, Quality Engineering Operations, Disposables & Accessories

PROCEPT BioRobotics Corporation -
San Jose, CA

Quick Apply

Job Details

Full-time
$220,500 - $259,410 a year

Benefits

Opportunities for advancement

Qualifications

Production data analysis
ISO standards
Quality control statistical data analysis
Spreadsheets
Presentations for conferences or internal meetings
Math
Managing engineering teams
Quality risk management
Medical device manufacturing facility experience
Engineering project budget management
Design engineering
Leading team collaboration initiatives
Regulatory/legal compliance standards in production
Data-driven problem-solving
Collaboration with manufacturing teams
Design controls
Biomedical regulatory compliance
Managing projects
Productivity software
Biomedical manufacturing processes
Legal compliance
Project risk management
General management
Program budgeting
Cross-functional communication
FDA regulations
Data analysis software

Full Job Description

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

Understanding PROCEPT's Culture

At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.

And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.

An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

The Opportunity That Awaits You:

As PROCEPT continues to grow and widen its global footprint, you’ll be responsible for production quality control and quality engineering support for sustaining development and maintenance of our disposables and accessories production.

You will provide quality engineering management oversight for specific elements supporting the sustenance, and maintenance of various aspects of quality systems and support any compliance related activities as required by the PROCEPT Quality Management System (QMS), which includes corrective and preventive action, training, document controls, and post market product improvements.

You’ll also be responsible for growing, developing, and manage a high performing team to interface with various cross functional teams across PROCEPT and support all the requisite product related quality engineering requirements.

What Your Day-to-Day Will Involve:

Overall leadership of quality engineering teams that support the Disposables & Accessories operations functions.
Hire, retain and lead a high-performance team that supports the relevant manufacturing operations, some of
which include in-process and final quality control, sustaining quality engineering, supplier quality, design transfer
of new products into manufacturing
Establish and build relationships with internal and external partners to support strategic business initiatives
Lead quality personnel in the completion of required departmental activities including objectives/ goal
Be able to lead, execute, and implement various improvement projects
Manage quality budgeting, including planning and managing to establish targets and plans
Support Lean/Six Sigma initiatives on our manufacturing line
Support DFX initiatives on the manufacturing line to ensure high product quality
Drive R&D/Advanced Manufacturing Engineering to provide Manufacturing designs with high process capability
Maintain job descriptions of subordinates. Orients new employees to the department and company
Assure that the department maintains an awareness and practice of employee safety
Manage and execute the overall quality engineering strategy for a particular product line or platform
Drive comprehensive and detailed Program plans to successful completion
Identify program risks and develop risk mitigation strategies to maintain program expectations
Identify program problems and drive solutions such as allocation of resources or changing specifications
Participate in formulating plans and objectives for the program area and generally review and approve projects and their implementation within the various functional areas
Assure the successful transition to manufacturing and satisfactory field service support to customer as required.
Travel to suppliers or contract manufacturers as needed

The Qualifications We Need You to Possess

College Degree required, B.S. in Science, Engineering or equivalent combination of education and experience. M.S. preferred
Experience working in a structured design process such as ISO13485 or FDA QSR, knowledge of regulatory approval process and requirements
8+ years of relevant experience in medical devices industry with at least 5 years in leadership roles
Experience in managing the following standards/requirements:
- ISO 13485 Medical Devices – Quality Management System
- US FDA CFR 21 Part 820 (QSR)
- ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
- Medical Device Directive (93/42/EEC - MDD)
- EU Medical Device Regulation (EU 2017/745)
- SOR/98-282 Canadian Medical Device Regulations
Experience working in a fast-paced, high growth environment
Proficient in project management tools like Smartsheet
Strong organizational skills, detail oriented. Exceptional oral and written communication skills
Experience with Microsoft Office including Microsoft Word, PowerPoint
Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
Ability to balance hands-on tasks and team management/budget planning functions
Experience with electronic QMS helpful
Experience working with electronic, software, and/or imaging devices is desirable
Experience in understanding complex data and analyzing that data to drive the right decisions
Ability to lead and collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Clinical Affairs, Marketing, Quality, etc.)
Excellent interpersonal and influence management skills including evidence of managing multi-disciplinary teams.
Ability to work to a deadline and to handle multiple tasks simultaneously.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write and review reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, individual contributors, and customers.
Ability to apply mathematical concepts such as multiplication, exponents, logarithms, and unit of measure conversions.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Pay Range for this role:

$220,500 to $259,410

Quick Apply

Refine Your Search

director of quality assurance jobs in fremont ca

Director, Quality Engineering Operations, Disposables & Accessories

Director, CMC QC Small Molecules

Director of Quality Assurance

Director Quality and Mission Assurance

Sr. Director, Quality Assurance for Quality Control

Head of Quality Assurance

Director, Quality Operations

Sr. Manager / Associate Director, Quality Audits

Director, Quality Assurance Operations

Director, Operations and Customer Quality Program Engineer

Senior Director / Director - CMC/GMP Quality Assurance

Associate Director of QC / HPLC

Associate Director, Quality Assurance - CMC Operations

Director Quality Assurance

Director, Quality Assurance

Director Supplier Quality

Senior Director, Reliability Engineering

Sr/Exec Director, Quality Assurance GCP

Associate Director, Quality Assurance Compliance

ASSOCIATE DIRECTOR, AUDIT QUALITY ASSURANCE - HYBRID

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