Senior Document Control Coordinator

Posted 2 Days Ago
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Plymouth, MN
Senior level
Healthtech • Manufacturing
The Role
The Senior Document Control Coordinator is responsible for ensuring compliance with quality management systems, managing the Change Control Process, preparing documentation, and maintaining document control systems. The role includes participation in audits, improving current processes, and overseeing the retention and management of records within the organization.
Summary Generated by Built In

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.

U.S. Applicants: EOE/AA Disability/Veteran

Top Skills

Change Control Process
Quality Management Systems
Sharepoint
The Company
HQ: Plano, TX
2,909 Employees
On-site Workplace
Year Founded: 1940

What We Do

Integer Holdings Corporation (NYSE:ITGR) is a leader in advanced medical device outsourcing (MDO) and serves its customers by providing comprehensive end-to-end solutions with its unparalleled expertise in innovation and manufacturing. Integer's vision is to enhance the lives of patients worldwide by being its customer's partner of choice for innovative medical technologies and services. Additionally, through Electrochem, an Integer company, it develops custom batteries for high-end niche applications in energy, military, and environment markets. The company's medical device manufacturing brands include Greatbatch™ Medical and Lake Region Medical™. Additional information is available at www.integer.net.

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