Sr. Document Control Coordinator

integer; Minneapolis (MN); On-site; USD 34,000 - 50,000; Full time

Benefits offered by this job

Comprehensive benefits package

Parental leave

401(k) with company match

Company holidays with PTO

Job summary

Integer is seeking a qualified Document Control Specialist to oversee the Quality System documentation. You will manage the Change Control Process, archive records, and administer the Document Control System to ensure compliance with current standards and regulations.

You will lead change requests, document control activities, audits, and file maintenance while collaborating with cross-functional teams to continuously improve processes and ensure data integrity within the QMS.

Qualifications

• Technical degree or higher with relevant experience in business or technical field.
• Specialized knowledge in Engineering and Documentation Control Systems.
• Strong ability to read and interpret technical drawings/prints and to write clearly.

Responsibilities

• Adheres to Integer's Values and safety, environmental, security and quality requirements incl. FDA regulations and QMS.
• Leads and maintains the Change Control Process with proper reviews and sign-offs.
• Maintains data distribution and expedites review and release of documentation.
• Analyzes and develops recommendations to improve current processes.
• Manages SharePoint Quality documentation and the Change Control Database.
• Collaborates with originators to prepare documents and resolve discrepancies.
• Participates in internal and external audits.
• Manages record retention processes.
• Participates in creating new processes to improve Quality System.
• Maintains active/obsolete/computerized files to support documentation system.
• Performs other functions as required.

Skills

Technical reading

Technical writing

Documentation control

Education

Technical Associate's degree

Bachelor's degree

Tools

SharePoint

QMS software

Job description

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

• Customer We focus on our customers' success
• Innovation We create better solutions
• Collaboration We create success together
• Inclusion We always interact with others respectfully
• Candor We are open and honest with one another
• Integrity We do the right things and do things right

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.