Document Control Specialist III

Description

Job Summary:

A Document Control Specialist in the medical device industry manages, organizes, and maintains controlled documents (SOPs, specifications, drawings) to ensure compliance with FDA 21 CFR Part 820.40, ISO 13485, and GMP standards. This role supports cross-functional teams by ensuring accurate lifecycle documentation, manage change requests, proper revision control, and timely distribution of quality and regulatory documents. This position leads projects related Document Control.

Responsibilities (Specific Tasks, Duties, Essential Functions Of The Job)

• Lead and oversee document control operations across multiple functions or sites. Participate in document change requests, updating, approving, and distributing documents while ensuring only the current versions are in use.
• Act as the document control SME for FDA, ISO 13485, MDSAP, and global regulatory inspections.
• Own and maintain document control procedures, templates, and governance models.
• Partner with Quality, Regulatory, R&D, Manufacturing, and Post Market teams to ensure document alignment.
• Manage complex document change initiatives, including system updates in document control system (MasterControl) and ERP system (Oracle).
• Lead configuration, enhancements, validation support, and user access governance within the electronic document control system (MasterControl).
• Develop and deliver training on document control best practices and regulatory expectations.
• Support reporting and trending analysis of Key metrics related to change requests and other document control activities; present insights to QA leadership.
• Mentor and provide functional guidance to junior document control staff.
• Support QMS integration during acquisitions, site expansions, or system transitions.
• Comply with all company policies and procedures. Assist with any other duties as assigned.
  
  

Required Qualifications & Skills:

• Associates degree or equivalent experience.
• 5+ years working experience in medical device document control or quality systems.
• Deep knowledge of FDA 21 CFR Part 820 (cGMP), ISO 13485 and global regulatory requirements
• Experience with electronic quality management systems, preferably MasterControl.
• High attention to detail in document formatting, numbering, and data entry.
• Sound verbal and written communication with Cross-functional members
  
  

Inogen assesses market data to ensure a competitive compensation package for our employees. The base salary for this position is expected to be between$70,000.00 and $85,000.00 annually. However,actualbase salary if hired will be determined on an individualized basisand will be based on non-discriminatory factors, includingas toindividual skills, education,experience and market location.

Our Benefits and Rewards:

In addition to the expected base salary, this role is eligible to participate inInogen’sannual performance bonus incentive plan,highly competitiveand company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provideshealth, dental, and vision insurance, 401(k) plan plus employer contribution and match, andgenerous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter.

Inogen is an Equal Employment Opportunity/Affirmative Action Employer - Underrepresented racial and ethnic groups/Females/Individuals with Disabilities/Protected Veterans.