Senior Quality Documentation & Change Control Lead

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

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.