Top 12 Quality engineer medical device Jobs in Petaluma, Ca

Quality Engineer
Abbott Laboratories —Santa Rosa, CA
- $90,000 - $180,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Experience equivalent to degree accepted
- Health insurance
- Tuition reimbursement
Manufacturing Quality Engineer
Collidion —Petaluma, CA
- Full-time
- Mid-level
- 3 years
- Master's degree
Design Engineer - Bioprocess Components
IDEX Health & Science LLC —Rohnert Park, CA
- $109,800 - $164,600 a year
- Online Application
- Mid-level
- Analysis skills
- Manufacturing
- Health insurance
- Paid time off
Principal R&D Engineer
Endologix —Santa Rosa, CA
- $145,000 - $167,500 a year
- Full-time
- 6 years
- Master's degree
- Doctor of Philosophy
- Commuter assistance
- Health savings account
Principal Design Assurance Engineer
Endologix —Santa Rosa, CA
- $135,000 - $157,500 a year
- Full-time
- Engineering
- Product management
- Experience equivalent to degree accepted
- Commuter assistance
- Health savings account
Sr. R&D Engineer
Endologix —Santa Rosa, CA
- $100,000 - $115,000 a year
- Full-time
- Engineering
- 11+ years
- Master's degree
- Commuter assistance
- Health savings account
R&D Engineer 3, Hardware
Keysight Technologies, Inc. —Santa Rosa, CA
- $106,130 - $176,880 a year
- Full-time
- Bachelor of Science
- Analysis skills
- Doctor of Philosophy
- Health savings account
- Employee stock purchase plan
7d
Reliability Engineer - Compound Semiconductor ICs
Keysight Technologies, Inc. —Santa Rosa, CA
- $138,960 - $231,600 a year
- Full-time
- Bachelor of Science
- Office
- Analysis skills
- Health savings account
- Employee stock purchase plan
3d
In-Fab Wafer Test Engineer
Keysight Technologies, Inc. —Santa Rosa, CA
- $93,050 - $155,080 a year
- Full-time
- Software troubleshooting
- Analysis skills
- Continuous improvement
- Health savings account
- Employee stock purchase plan
Chief RF Engineer
Emerson —Santa Rosa, CA
- $180,872 - $248,700 a year
- Full-time
- Hybrid work
- Master's degree
- Doctor of Philosophy
- Travel
- Profit sharing
- Paid parental leave
Semiconductor Die Fab Process Engineer
Keysight Technologies, Inc. —Santa Rosa, CA
- $103,850 - $173,080 a year
- Full-time
- Bachelor of Science
- Assembly
- Analysis skills
- Health savings account
- Employee stock purchase plan
Tooling Engineer III
SMC Ltd. —Santa Rosa, CA
- $86,000 - $135,000 a year
- Full-time
- Background check
- Engineering
- Pass drug screening
- Paid holidays
- Disability insurance
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12d

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Quality Engineer II
Abbott Laboratories —Alameda, CA
Minimum 5 years applicable technical/engineering experience and demonstrated use of Quality tools/methodologies.
$90,000 - $180,000 a year
Manufacturing Quality Engineer
Collidion —Petaluma, CA
Identifies and resolves production and manufacturing problems or issues using quality tools and techniques such as root cause analysis, statistical analysis,…

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Sr Device Assembly Engineer
Amgen —New Albany, OH
The engineer serves as a technical subject matter expert, partnering across Device Engineering, equipment system owners, Combination Products Organization,…
$115,494.60 - $156,257.40 a year
14d
Associate Packaging Engineer - Columbus, OH
Abbott Laboratories —Columbus, OH
Bachelor of Science Degree in Packaging, Engineering, or related technical field and/or 1+ years packaging technical experience. ISTA certification is a bonus.
$50,700 - $101,300 a year
6d

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quality engineer medical device jobs near petaluma, ca

Quality Engineer

Abbott Laboratories -
Santa Rosa, CA

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Job Details

Full-time
$90,000 - $180,000 a year

Benefits

Health insurance
Tuition reimbursement
Retirement plan

Qualifications

Defect resolution root cause analysis
ISO standards
Corrective and preventive actions (CAPA)
Manufacturing facility experience
Medical device manufacturing facility experience
CLIA regulations
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Root cause analysis
FDA regulations
Laboratory compliance and regulatory documentation
Quality assurance experience within healthcare

Full Job Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Quality Engineer

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
This position works out of our Santa Rosa, CA location in the Toxicology business within Abbott's Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

The Quality Engineer will execute highly complex and specialized quality assurance projects supporting Abbott's Toxicology business, including clinical and forensic laboratory operations, drugs-of-abuse testing, quality systems compliance, and continuous improvement initiatives. This role applies advanced quality principles and analytical techniques to ensure compliance with applicable regulatory, accreditation, and quality standards. The Quality Engineer will serve as a key contributor to Quality Management System effectiveness, laboratory quality oversight, audit readiness, validation activities, process improvement, and regulatory compliance while partnering cross-functionally to deliver high-quality products and services that meet customer and business requirements.

What You’ll Work On

Works on problems of diverse scopes and complexity where analysis of data, regulatory requirements, and considerable judgment and initiative are required to reach resolution or provide recommendations.
Leads and/or contributes to quality system, test method, quality assurance, and operational process improvement projects.
Supports and may administer Quality Management System processes including CAPA, document control, training, supplier quality, change control, management review, and quality metrics.
Conducts complex analysis of quality records, laboratory data, audit findings, investigations, trends, and reports to identify opportunities for continuous improvement.
Supports equipment, process, facility, software, and test method qualification, validation, verification, and change control activities.
Conducts inspection, verification, and validation of components, materials, systems, and processes used in development, laboratory, and manufacturing activities.
Conducts and supports internal audits and external inspections, including CLIA and CAP, customer, and supplier audits, and ensures timely implementation of corrections and corrective actions.
Identifies and addresses recurring quality, compliance, and operational issues impacting product quality, laboratory testing, data integrity, or regulatory compliance.
Develops, tracks, analyzes, and trends quality metrics and key performance indicators and communicates results to management.
Documents quality issues, investigations, nonconformances, CAPAs, effectiveness checks, and performance measures for management review.

Required Qualifications

BS/BA degree or equivalent in chemistry, biology, or other scientific discipline or equivalent experience.
Minimum of five to eight years of Quality Assurance experience in a regulated FDA medical device manufacturing environment or ISO certified laboratory, with 3-5 years progressively responsible positions.
Experience implementing, leading, or coordinating electronic document controls or CAPA program, including practical application of root cause analysis tools.
Thorough knowledge and experience implementing quality Systems Regulations ISO 17025,13485, CLIA, or 21 CFR 820.

Preferred Qualifications

Proven experience leading and maintaining Quality Management Systems (QMS), including CAPA, audits, document control, training, change control, nonconformance management, management review, and continuous improvement programs.
Regulatory & Compliance Knowledge: Strong understanding of CLIA, CAP accreditation requirements, laboratory quality systems, data integrity, quality control, proficiency testing, and applicable state and federal regulations.
Technical & Analytical Capabilities: Experience with root cause analysis, risk assessment, method validation/verification, equipment qualification, quality metrics, KPI reporting, internal audits, and regulatory inspection readiness.
Leadership & Communication Skills: Excellent technical writing, problem-solving, organizational, and cross-functional collaboration skills, with proficiency in eQMS platforms, document management systems, LMS tools, and Microsoft Office applications.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.

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Refine Your Search

quality engineer medical device jobs in petaluma, ca

Quality Engineer

Manufacturing Quality Engineer

Design Engineer - Bioprocess Components

Principal R&D Engineer

Principal Design Assurance Engineer

Sr. R&D Engineer

R&D Engineer 3, Hardware

Reliability Engineer - Compound Semiconductor ICs

In-Fab Wafer Test Engineer

Chief RF Engineer

Semiconductor Die Fab Process Engineer

Tooling Engineer III

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