QA Manager Job Listing at Kelly Services in Petaluma, CA (Job ID US3632025_BH10046374)

Description

Kelly Engineering has an outstanding opportunity for a contract to hire QA Manager role with an organization that is committed to advancing solutions for some of the most challenging issues in healthcare in Petaluma, CA.

You will be working with innovative technologies to improve outcomes across a wide range of medical applications, from patient care settings to medical product development. With substantial growth ahead and an upcoming public offering, this is an exceptional opportunity to join a dynamic company offering significant equity potential.

The QA Manager will lead our Quality Assurance department and drive compliance for pharmaceutical and combination product regulations. You'll be critical for our major product launch and key to building robust quality processes for future growth

Key Responsibilities:

• Build, scale and manage the QA team; hire and mentor quality staff
• Ensure regulatory compliance with GMP, FDA, ISO13485 and combination product requirements
• Oversee launch readiness and quality activities to meet urgent product timelines
• Develop and implement SOPs, validation protocols, and quality documentation systems
• Lead audit and inspection preparation
• Drive root cause analysis, CAPA programs, and continuous improvement.
• Engage with R&D, manufacturing, and regulatory teams to align quality and business goals

What We Are Looking For:

• 8+ years of Quality leadership experience in a pharmaceutical environment (combination product experience a plus).
• Expertise in FDA regulations, ISO standards, drug/device compliance
• Demonstrated ability to build and scale high-performing quality teams
• BS/MS in a related discipline

What happens next:
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in the Kelly Engineering network. That means our team of expert engineering recruiters will have access to your profile, making your opportunities limitless.

 

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.

 Apply on company website