Quality Engineer Job Listing at Kelly Services in Petaluma, CA (Job ID US3614460_BH9998191)

Description

Job Title: Quality Engineer – Medical Devices (Contract-to-Hire)
Location: Petaluma, CA
Pay Rate: $60–$72/hr (based on experience)

Overview:
Kelly Engineering is seeking a Quality Engineer for a fast-growing medical device manufacturer developing combination products (device + drug). This is an urgent contract-to-hire role to support product launch readiness. The engineer will be the on-site quality lead ensuring compliance with GMP, FDA, and ISO 13485 requirements.

Key Responsibilities:

• Develop, revise, and execute SOPs, work instructions, and validation protocols (IQ/OQ/PQ).

• Implement and maintain quality systems in compliance with GMP and FDA requirements.

• Lead CAPA investigations, risk assessments, and root cause analysis.

• Collaborate with Regulatory, Manufacturing, and Operations teams to ensure compliance.

• Support internal and external audits (FDA, ISO).

• Serve as the on-site quality presence, ensuring timelines are met and proactively communicating risks.

Qualifications:

• 3–5 years of Quality Engineering experience in medical devices (required).

• Knowledge of GMP, FDA 21 CFR Part 820, and ISO 13485.

• Strong communication skills with ability to challenge decisions and advocate for compliance.

• Experience working in fast-paced, startup-like environments.

• Bachelor's degree in Engineering, Life Sciences, or related field preferred.

• CQE, Six Sigma, or related certification a plus.

• Experience with combination products and validation documentation preferred.

Details:

• Contract-to-Hire

• Full-time, On-site (Petaluma, CA)

• Pay: $60–$72/hr

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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