Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Document Control Coordinator will maintain the entire document control program to ensure compliance with domestic and international medical device regulations. This role supports the coordination, processing, and maintenance of controlled documents and training records within the Quality Management System (QMS).
Responsibilities include executing document control processes, ensuring timely processing of changes, maintaining accurate records, and supporting site-wide documentation and training activities. The Document Control Coordinator partners with cross-functional teams to ensure documentation accuracy, availability, and compliance.
SUPERVISION RECEIVED
Reports to the Manager, Quality Assurance & Compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
Process document changes (e.g., SOPs, work instructions, forms) in accordance with document control procedures
Maintain and organize controlled documentation, including DHRs, DHFs, and DMRs, ensuring accuracy and completeness
Coordinate document review, approval, and release workflows within the electronic document management system
Ensure timely processing of document changes to support business and regulatory requirements
Support training record management, including assignment and tracking of training completions
Retrieve and provide documentation in support of internal and external audits
Ensure document storage and retention practices comply with QMS requirements
Identify and communicate potential process improvements within document control workflows
Maintain accurate records and ensure data integrity across systems
Collaborate with cross-functional teams to resolve documentation or training-related issues
Perform administrative tasks related to document control and records management as needed
Support continuous compliance with FDA and ISO regulatory requirements
All other tasks / duties as assigned
DESIRED MINIMUM QUALIFICATIONS
Associate degree in Business Administration or related discipline preferred
2-5 years of experience in document control, records management, or regulated industry environment
Working knowledge of QSR/GMP (21 CFR Part 820) and ISO 13485 requirements preferred
Familiarity with document control systems and electronic quality systems (e.g., Agile) preferred
Understanding of 21 CFR Part 11 requirements preferred
Strong organizational skills and attention to detail
Effective written and verbal communication skills
Ability to manage multiple priorities and meet deadlines
Proficiency in Microsoft Office (Word, Excel, PowerPoint, SharePoint, Adobe Acrobat)
Ability to work collaboratively across functions
PHYSICAL REQUIREMENTS
Routine activities include but are not limited to: using computers, standing, walking, writing by hand, lifting, carrying, pushing, and pulling objects.
Salary Pay Range:
$23.28 - $31.46 USD Hourly
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
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