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Integer Holdings Corporation

Medical device CDMO for cardiac devices

Associate Document Control Administrator

Office Clerical & RecordsConfirmed live in the last 24 hours
Full-timeAlden, NY, USAIn-person

About the Job

Requirements

  • A high school diploma or equivalent may be required.
  • Requires 0–1 years of experience in entry-level administrative duties and the ability to work under close supervision.
  • Accountable for own contribution.
  • Uses basic oral and written communication skills.
  • Has organizational skills, including time management and the ability to prioritize and meet deadlines.
  • Has general computer operation skills, including Microsoft Teams, Excel, and Word.
  • Pays attention to detail when reviewing and preparing documents.
  • Uses existing procedures to solve problems and engages in continuous improvement activities.
  • Has a basic understanding of electronic documentation systems.
  • Has a basic understanding of Quality Management Systems, including ISO 9001, ISO 13485, and FDA 21 CFR Part 820.
  • Has office management and administration skills.

Responsibilities

  • Adhere to company policies and procedures and all safety and quality requirements, including Quality Management Systems, Environmental and Security Management Systems, U.S. Food and Drug Administration regulations, company policies and operating procedures, and other regulatory requirements applicable to the location.
  • Provide administrative 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 and complete quality records, reports, and documentation while ensuring Good Documentation Practices are applied.
  • Review Device History Records in accordance with applicable procedures and Good Documentation Practices.
  • Assist the Quality department during audits.
  • Perform other duties as required.
  • Expand skill base through on-the-job training, cross training, and classroom instruction.
  • Provide data to other departments.
  • Continually seek to drive improvements in process quality.
  • Identify and escalate quality non-conformances to assist in achieving company quality objectives and key business metrics.
  • Adhere to Integer Core Beliefs, Safety and Quality requirements, and applicable regulations described in the Quality Management System.
  • Assure adherence to the Quality Management System in daily work.
  • Actively support the site's Environmental, Health and 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 assigned goals and objectives.

About the Company

Integer Holdings Corporation

Medical device CDMO for cardiac devices

Integer Holdings Corporation is a large medical device CDMO that serves cardiac rhythm management, neuromodulation, and cardiovascular markets. It designs, develops, and manufactures device components and subassemblies through its brands Greatbatch Medical, Lake Region Medical, and Electrochem. The company differentiates itself by its scale, broad capabilities across multiple medical specialties, established brands, and global manufacturing footprint, enabling reliable supply for device makers. Its goal is to help medical device companies bring safe, effective technologies to market and improve patients’ lives worldwide.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Wilmington, DE
Founded
1940

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