Document Control Administrator

Integer Holdings; Plymouth (MN); On-site; USD 28,000 - 40,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Disability insurance

401(k) with company matching

Paid time off and holidays

Parental leave

Job summary

Integer Holdings is seeking a documentation administrator to support the Quality function in a GMP/GDP environment. You will administer change records, control document access, and prepare quality records and reports.

Under defined procedures, you will review device history records, assist audits, and provide data to other departments while maintaining compliance with QMS and regulatory requirements.

Qualifications

• High school graduate or equivalent may be required; experience in administration preferred.
• 2–3 years of experience; skills developed on the job; ability to work under moderate supervision.
• Working knowledge of Quality Management Systems (e.g., ISO9001, ISO13485, FDA 21CFR Part 820) and electronic documentation systems.

Responsibilities

• Support and perform documentation administration within the Quality function, adhering to GMP and GDP guidelines.
• Follow clearly defined procedures or operate under moderate supervision.
• Adhere to Quality Management System requirements and regulatory requirements.
• Administer change records, control access to documents, and notify applicable functions of document changes.
• Assist audits and provide data/analysis to other departments.

Skills

Leadership

Effective communication

Time management

Organization

Office software

Attention to detail

Problem Solving

Education

High school diploma

Tools

Microsoft Teams

Excel

Word

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

Who we are:

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance the lives of patients worldwide and high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.

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 moderate 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 data and analysis to other departments.

• 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).

• 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).

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:

  • High school graduate or equivalent may be required. Experience in administration activities preferred.

• Minimum Experience:

  • 2-3 years of experience. Skills developed through on the job training. Capable of working under moderate Supervision.

Special Skills:

• Leadership

  • Accountable for own contribution

• Effective communication skills (both oral and written)

  • Uses communication skills to exchange important 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 recognizing and solving routine problems without supervision.

• Specialized Knowledge:

  • Working knowledge of

  • Electronic documentation systems

  • Understanding of 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.