Reports to: Director of Quality Assurance

Workplace type: Hybrid (4 days a week, 1 remote)

About the Role

We’re looking for a highly motivated Document Control Specialist to take ownership of document and training processes in an innovative medical device startup. This is not a maintenance role—you will help build, improve, and scale our document control and training systems as we move from development into clinical and beyond.

Description

• Own and manage document workflows within the eQMS, ensuring accuracy, traceability, and audit readiness
• Drive the full document lifecycle (creation, review, approval, release, revision, archival) with minimal oversight
• Track and push Change Orders (DCNs) from initiation through closure—keeping cross-functional teams aligned and unblocked
• Partner with Engineering, Quality, and Regulatory to support Design Control documentation (DHF, DMR, DHR)
• Build, execute, and maintain employee training programs and training records
• Support internal and external audits, including preparation, participation, and rapid closeout of findings
• Perform completed quality record review/approval Proactively identify gaps and improve SOPs, templates, and document control workflows
• Contribute to broader Quality activities as needed (metrics, CAPA support, compliance initiatives) in a fast-paced startup environment.

Skills:

• Strong organizational and prioritization skills in rapid-growth environments
• High attention to detail with a process-oriented mindset
• Clear, effective communication across cross-functional teams
• Ability to operate independently and take ownership of outcomes
• Proficiency in Microsoft Office tools
• Collaborative, hands-on approach with a willingness to “jump in” where needed
• Continuous improvement mindset—comfortable building and refining processes

Requirements:

• Bachelor’s degree (BA/BS) or equivalent experience
• 3+ years of experience in document control or quality within a regulated industry (medical device preferred)
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485
• Experience using eQMS/PLM systems to manage controlled documentation (experience with Propel preferred)
• Experience supporting or interfacing with Design Controls (DHF/DMR/DHR)
• Experience supporting audits and/or CAPA activities is a plus
• Comfortable working in a fast-paced, evolving startup environment with shifting priorities

Why Join Us

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like. We enjoy time inside the office and out!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.