Supervisor, Medical Device Documentation Control

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Position Overview:

The Supervisor, Document Services is responsible for managing day‑to‑day coordination and oversight of document and records control within the Quality Management System (QMS).  Works closely with stakeholders to support an effective and efficient document change management process that meets business needs.  The supervisor leads a team to maintain document integrity, security, and accessibility, while driving continuous improvement activities by identifying opportunities to enhance process efficiency and scalability.  Ensures applicable QMS regulatory requirements and standards including but not limited to FDA 21 CFR Part 820, ISO 13485 are properly followed within the Document and Records Control processes and supports ongoing compliance efforts as well as internal and external audits.

Responsibilities:

·       Supports the QMS Process Group activities for Document, Record, and Change Controls, ensuring procedures are followed and issues are escalated appropriately.

·       Assists in the development, deployment, and maintenance of document control tools and processes.

·       Coordinates and delivers training related to Change Order processes and supports the certification program.

·       Provides day‑to‑day oversight and direction for project contractors and vendor resources supporting document control activities.

·       Supports business initiatives by monitoring document control trends and recommending practical improvements to enhance efficiency and scalability.

·       Maintains awareness of document control workflows, prepares routine reports and metrics, and contributes to Monthly Data Analysis and Management Review as needed.

·       Participates as a QMS representative in Document & Record Control improvement projects, contributing operational insight.

·       Works cross‑functionally to improve the quality and completeness of change order documentation prior to approval.

·       Supervises and develops document control staff, providing coaching, performance feedback, and training to support professional growth.

·       Builds a collaborative, customer‑focused team environment that emphasizes accuracy, accountability, and strong internal service.

·       Performs other related duties as assigned to support document control operations.

Education and Experience:

Minimum Requirements:

• PA or Bachelor´s degree from an accredited University, or an equivalent combination of education and relevant work experience.

• Working knowledge of Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.

• Minimum of 7 years of experience in a regulated industry, preferably medical device, including 3+ years in Quality Assurance, Regulatory Affairs, or Document Control, and 3+ years leading or supervising staff.

• Familiarity with FDA and ISO 13485 audit and certification activities.

• Working knowledge of 21 CFR Part 11 and experience supporting implementation or maintenance of compliant systems.

• Proficiency with Microsoft Office applications (Word, Excel, Access, PowerPoint).

• Experience contributing to and leading continuous improvement initiatives within document control or quality systems.

Preferred Skills and Competencies:             

• Experience supporting the implementation or improvement of electronic document control systems.

• Strong verbal and written communication skills suitable for guiding staff and collaborating with cross‑functional teams.

• Ability to communicate effectively across multiple levels of the organization.

• Demonstrated ability to generate, organize, and maintain accurate and compliant records.

• Strong task‑management skills with the ability to organize workload, balance priorities, and meet deadlines.

• Ability to work effectively with individuals of varying technical backgrounds; must be detail‑oriented, highly organized, and able to deliver accurate results while maintaining a customer‑service mindset.

• Ability to foster a positive, “can‑do” attitude within the Document Services Specialist team, supporting high performance and consistent output in a fast‑paced environment.

KPIs and Performance Expectations:           

·       Document processing turnaround time (e.g., average time to approve and release documents).

·       Accuracy rate of document revisions and compliance checks.

·       Training completion rate for document control procedures meets target goals.

·       Completion of assigned continuous improvement initiatives implemented per quarter.

Physical Requirements (if applicable):            

• Ability to foster a positive, “can‑do” attitude within the Document Services Specialist team, supporting high performance and consistent output in a fast‑paced environment.

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.