Document Control Coordinator

Integer Holdings; Plymouth (MN); On-site; USD 28,000 - 41,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) with company matching

Paid time off and holidays

Job summary

Integer Holdings is seeking a documentation administrator within the Quality function to support GMP and GDP compliant processes. The role includes managing controlled documents, assisting in change records, and ensuring adherence to QMS and regulatory requirements.

You will collaborate with multiple departments, train personnel on systems, and participate in audits to ensure data integrity and quality across the organization.

Qualifications

• Diploma or equivalent in administration is preferred.
• 4+ years of experience in documentation/admin within a quality/GMP context.
• Experience with Quality Management Systems (QMS) and regulatory requirements is expected.

Responsibilities

• Support and perform documentation administration within the Quality function under GMP and GDP guidelines.
• Assist change record implementation per SOPs and manage controlled documents.
• Review Device History Records and participate in audits as needed.
• Train personnel on systems and processes and provide guidance to other departments.

Skills

Leadership

Effective communication

Time management

Microsoft Teams

Excel

Word

Attention to detail

Problem Solving

Education

Diploma / or equivalent in administration

Tools

Microsoft Teams

Excel

Word

Electronic documentation systems

Documentation control

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

What you will do in this role:

The primary purpose of this position is to support and perform documentation administration activities within the Quality function, adhering to Good Manufacturing Practices (GMP) and Quality system guidelines. Carries out responsibilities under clearly defined procedures and / or under minimum supervision.

• Adhere to company policies and procedures and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental and Security Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements as required in your location.
• Provide administrator support for change record implementation in line with standard operating procedures.
• Control distribution and retrieval of documents including electronic files of controlled documents.
• Notify applicable functions when local external documents change (as required).
• Manage and control access to on-site and off-site records and documents.
• Perform annual record disposition review.
• Compile / complete quality records, reports and / or documentation ensuring Good Documentation Practices (GDP) are applied.
• Review Device History Record (DHR) in accordance with applicable procedures and Good Documentation
• Assist the Quality department during audits.
• Provide support / guidance and analysis to other departments.
• Train personnel in proper techniques to utilize systems, and processes.
• Performs other duties as required.

Grow on the job and help others succeed.

• Expands skill base through on-the-job training, cross training, and classroom instruction.

Ensure Alignment on the Corporate Strategic Initiatives

• Continually seeks to drive improvements in process quality.
• Identifies and escalates quality non-conformances to assist in achieving company quality objectives and key business metrics.
• Adheres to Integer Core Beliefs, Safety and Quality requirements and applicable regulations described in the quality management system (QMS).
• You embed Quality within your daily work life - "I own Quality." You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI's and journey to 5 Sigma.

How you will be measured:

The specific measures listed below may be subject to change and are not intended to be an all-inclusive list.

• Safety is our highest priority; you are an active supporter of the Integer Environmental, Health & Safety programs.
• Live the Integer Values through leading by example.
• Assist the site in achieving its annual goals for safety, quality, delivery, cost, and inventory.
• Achieve all Goals and Objectives assigned.

What sets you apart:

• Minimum Education:
  • Diploma / or equivalent in administration preferred.
• Minimum Experience:
  • 4+ years of experience. Expertise developed through on the job training and job experience.

• Special Skills:
  • Leadership
    • Provides subject matter guidance for junior team members and other users.
  • Effective communication skills (both oral and written)
    • Advance communication skills to communicate complex detailed information.
  • Strong organizational skills (including time management and ability to prioritize and meet deadlines).
  • General computer operation skills (e.g., Microsoft Teams, Excel, Word)
  • Attention to detail when reviewing and preparing documents.
  • Problem Solving
    • Capable of identifying creative solutions for atypical problems.

• Specialized Knowledge:
  • Proficient Understanding of
  • Electronic documentation systems
  • Quality Management Systems (e.g., ISO9001, ISO13485, FDA 21CFR Part 820)
  • Office Management and Administration skills

Salary range for this position is $20.23 - $29.67 per hour

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.