Quality Assurance Associate

Kelly Science, Engineering, Technology & Telecom – Pay Range

This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience—talk with your recruiter to learn more.

Base pay range: $95,000.00/yr - $/yr

Kelly Engineering has an outstanding opportunity for a contract to hire Senior QA Associate 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 Associate will assist in leading the 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.

• Assist the QA Manager in building, scaling and managing the QA team
• Ensure regulatory compliance with GMP, FDA, ISO
  13485 and combination product requirements
• Assist in launch readiness and quality activities to meet urgent product timelines
• Develop and implement SOPs, validation protocols, and quality documentation systems
• Assist in 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

• 5+ years of Quality experience in a pharmaceutical environment (combination product experience a plus)
• Expertise in FDA regulations, ISO standards, drug/device compliance
• BS/MS in a related discipline

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.

Mid-Senior level

Full-time

Quality Assurance and Manufacturing

Pharmaceutical Manufacturing

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