Document Control Specialist

Description / Core Responsibilities:

Manage document workflows within the electronic document control system (Propel), including document creation, revision routing, approval, release, and obsolescence.

· Track and support change orders from creation through release; follow up with owners and approvers to maintain timely execution.

· Support creation, revision, formatting, routing, and periodic review of controlled documents, including work instructions (WIs), SOPs, forms, and templates related to the Document Control function.

· Partner with Quality and cross-functional subject matter experts to draft, edit, and update WI/SOP content, ensure alignment with current practices, and coordinate training impact assessment as applicable.

· Create and execute training programs and maintain training records for all employees.

· Manage and maintain the in-house electronic Standards library for controlled external standards, including indexing, controlled access, version/revision status, renewal or availability tracking, and communication of updates to affected stakeholders.

· Organize and maintain Quality Records within the SharePoint records repository, including folder structure, naming conventions, indexing/metadata, retention support, and general record completeness and traceability.

· Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings.

· Support quality system process metrics and document control improvement activities.

· Provide ancillary QA support, as needed, for Device History Record (DHR) and Nonconformance Report (NCR) reviews, including documentation completeness checks, records retrieval, routing support, and follow-up on documentation gaps.

· Perform other quality responsibilities as assigned.

Skills:

Proficiency with Microsoft Office applications and familiarity with SharePoint-based records organization.

· Experience using electronic document control, eQMS, ePLM, or records management systems.

· Strong technical writing, editing, proofreading, and document-formatting skills for controlled procedures, WIs, SOPs, forms, and templates.

· Ability to interpret and organize controlled quality records while maintaining high attention to data integrity, traceability, and Good Documentation Practices.

· Excellent organizational and prioritization skills with the ability to manage multiple documents, change orders, records, and stakeholder follow-ups independently.

· Detail-oriented, collaborative, proactive, and comfortable communicating with cross-functional teams.

· Ability to support audits, quality records requests, and issue-resolution follow-up in a regulated quality environment.

Requirements:

BA/BS with 3+ years of work experience in a regulated healthcare industry segment (medical device, biopharma, diagnostics) in a document control, quality systems, or quality records role.

· Experience working within quality processes governed by regulatory standards, including 21 CFR Part 820/QMSR and ISO 13485.

· Demonstrated experience managing controlled documents through revision, approval, release, training, and archival/obsolescence workflows.

· Experience drafting, revising, or maintaining quality procedures, WIs, SOPs, forms, and templates.

· Experience organizing electronic records repositories, preferably SharePoint, with an emphasis on file structure, naming conventions, indexing/metadata, access coordination, and retention support.

· Experience maintaining or administering an electronic Standards library is preferred.

· Experience with key systems such as Microsoft Office and ePLM/eQMS systems; experience using Propel eQMS is preferred.

· Familiarity with Good Documentation Practices, quality record requirements, DHR documentation, and NCR processes is preferred.

· Flexible and comfortable in a fast-paced work environment.

Why Join Us:

We offer a fun, hands-on, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
We offer projects and training to continue your learning and technical growth.
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 or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!