Sr. Document Control Coordinator

Integer Holdings Corporation; Minneapolis (MN); On-site; USD 34,000 - 50,000; Full time

Job summary

Integer Holdings Corporation in Minnesota is seeking a qualified professional to manage Quality System Document Control. The role administers the Change Control Process, maintains records, and ensures compliance with FDA and related standards.

The position involves coordinating reviews, signing off on changes, and supporting audits while maintaining SharePoint documentation and retention processes.

Qualifications

• Technical Associate’s degree with 5-7 years experience in business or technical field OR Bachelor’s degree with 2 years of experience in related field.
• Specialized knowledge in Engineering and Documentation Control Systems.
• Ability to read and develop technical drawings/prints and strong technical writing skills.

Responsibilities

• Adheres to FDA regulations and quality requirements and company policies.
• Leads and maintains the Change Control Process with proper reviews and sign-off.
• Maintains data distribution systems and timely release of documentation.
• Participates in audits and manages file archives and the Change Control Database.
• Interfaces with originators to prepare documents and resolve discrepancies.

Skills

Document control

Technical writing

Reading drawings

Education

Technical Associate’s degree + 5-7 years

Bachelor’s degree + 2 years

Job description

Job Summary:

The primary purpose of this job is to perform all of the Quality System Document Control functions including the management of the Change Control Process, filing and archiving of records, and serve as administrator of the Document Control System to assure compliance to current standards and regulations.

Accountabilities and Responsibilities:

• 1. Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• 2. Leads and maintains the Change Control Process. This includes the preparation of the change requests, insuring the appropriate functional reviews and sign-off, and maintaining the records of the changes. Posts changes to computerized or manual records, releases documents, and notifies affected departments.
• 3. Maintains an established data distribution system and expedites review, signature approval and release of documentation in a timely manner.
• 4. Analyzes and develops recommendations to improve current processes.
• 5. Responsible for managing SharePoint Quality documentation and maintaining the Change Control Database.
• 6. Confers with change originators to prepare documents and change requests. Works with document originators to resolve discrepancies in order to make required changes to the documentation.
• 7. Actively participates in external and internal audits.
• 8. Responsible for record retention process.
• 9. Participates in the creation of new processes to improve Quality System.
• 10. Manages and maintains active, obsolete, and computerized files which support the documentation system.
• 11. Performs other functions as required.

Job Requirements:

• Minimum Education & Experience: Technical Associate’s degree with 5-7 years experience in business or technical field OR Bachelor’s degree with 2 years of experience in related field.
• Specialized Knowledge: Previous experience in Engineering and Documentation Control Systems.
• Special Skills: Ability to read and develop technical drawings/prints and solid technical writing skills.

Pay Range $24.59-$36.07

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base wages, a cash-based incentive program supporting our pay-for-performance philosophy, overtime pay, shift differentials, and call-in pay, when applicable. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical® and Lake Region Medical®.

Additional information is available at www.integer.net. Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination. Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment. Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at [phone] or via [e-mail] so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in to https://integer.wd1.myworkdayjobs.com/en-US/External/login For remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington. To review the Integer Applicant Global Privacy Statement, please click link below for your preferred language: English| Spanish| Malay| Chinese Thanks for your interest in working on our team!!