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Integer Holdings Corporation is seeking a documentation administrator to support GMP-compliant documentation control. The role involves adhering to QMS and GDP guidelines, managing document access, and assisting with audits.
Responsibilities include change-record support, distribution control, and data analysis across quality functions, with daily tasks under defined procedures. Join a team focused on excellence in medical devices and energy applications.
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.
We focus on our customers’ success
We create better solutions
We create success together
We always interact with others respectfully
We are open and honest with one another
We do the right things and do things right
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.
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.
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).
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.
Minimum Education:
Minimum Experience:
Leadership
Effective communication skills (both oral and written)
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
Specialized Knowledge:
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.