Quality Document Control Specialist

Kelly Engineering has an outstanding opportunity for a contract to hire Quality Document Control Specialist 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.

What you will do:

• Maintain and administer document control processes, including SOPs, work instructions, batch records, and quality records
• Support compliance with ISO 13485 and FDA 21 CFR Parts 210 & 211 (cGMP) requirements
• Manage document lifecycle activities (creation, revision, approval, archival)
• Support CAPA, deviation, and change control processes
• Assist with internal audits, inspections, and audit readiness activities
• Work closely with Manufacturing, R&D, and Regulatory teams to ensure documentation alignment and compliance

Qualifications:

• Strong working knowledge of ISO 13485 & FDA 21 CFR Parts 210 & 211 required
• Hands-on experience with document control systems (eQMS preferred)
• BS Degree in a related discipline
• High attention to detail and strong organizational skills

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