Senior Document Control Coordinator

Integer Holdings Corporation; Plymouth (MN); On-site; USD 34,000 - 50,000; Full time

Benefits offered by this job

Medical, dental, vision, disability, &

Life insurance & adoption benefits

401(k) plan with company matching

Holiday leave & PTO

Parental leave after one year

Job summary

Integer Holdings Corporation in Plymouth, MN is seeking a Documentation Administrator to support GMP-compliant documentation activities within the Quality function. You will control document distribution, maintain records, and assist with audits while following GDP/QMS guidelines.

The role requires strong organizational and communication skills, with a focus on training staff and driving continuous improvements in process quality.

Qualifications

• Diploma in administration preferred.
• 4+ years of experience.
• Experience gained on the job.
• Leadership and mentoring for junior staff
• Strong written and oral communication
• Excellent organization and time management
• Proficient in MS Office and document systems
• Knowledge of GMP, GDP, QMS ISO standards

Responsibilities

• Support documentation administration within Quality following GMP and GDP.
• Control distribution and retrieval of documents.
• Notify functions when local external documents change.
• Manage access to on-site and off-site records.
• Perform annual record disposition review.
• Review Device History Record (DHR) per procedures.
• Assist audits and support other departments.
• Train personnel on systems and processes.
• Drive process improvements and quality KPI attainment.

Skills

Leadership

Communication

Time management

Documentation systems

MS Office

ISO 9001

ISO 13485

FDA 21 CFR 820

Office management

Team mentorship

Education

Diploma in Administration

Tools

Microsoft Teams

Excel

Word

Job description

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 – “IownQuality.” 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 $24.59 - $36.07 per hour

Benefits:

• 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.

Equal Opportunity Statements:

Integer Holdings Corporation ("Integer") is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics.

We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination.

Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active‑dut wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans".

It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements.

Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons.

If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at [phone] or via [e-mail] so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening.

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