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Integer Holdings Corporation

Medical device CDMO for cardiac devices

Quality Technician 2

Inspection & Test +1Confirmed live in the last 24 hours
Full-timeBrooklyn Park, MN, USAIn-person

About the Job

Requirements

  • High school graduation or equivalent may be required; an associate degree or experience in the technical area may be preferred.
  • Two years of Integer work experience or three years of related manufacturing industry experience may be required; an associate degree may substitute for the years of experience.
  • Understanding of geometric dimensioning and tolerancing.
  • Understanding of ISO 9001 and ISO 13485 quality standards is preferred.
  • Product knowledge is helpful.
  • Computer operation skills.
  • Ability to read and interpret drawings and prints.
  • Ability to read and understand work instructions.
  • Experience using measurement tools and equipment and hand gauges to measure physical dimensions on parts, such as pin gauges, calipers, and optical comparators.
  • Organizational and communication skills.
  • Attention to detail and organization.

Responsibilities

  • Ensure or establish controls for products and processes related to technical functions so that customer and regulatory requirements are met.
  • Maintain and improve Integer quality systems.
  • Compile or complete quality records, reports, and documentation while applying Good Documentation Practices.
  • Participate in problem solving and provide input for process and product evaluations for continuous improvement.
  • Use equipment and ensure it is currently calibrated; repair, modify, or maintain equipment as needed.
  • Perform inspections in accordance with authorized specifications and applicable quality standards.
  • Recommend improvements to existing work instructions to improve quality, clarity, or efficiency.
  • Set up and run testing according to procedures or Engineering direction; perform failure analysis or troubleshooting as needed.
  • Expand the skill base through on-the-job training, cross-training, and classroom instruction.
  • Train personnel in proper techniques for using systems, equipment, and processes as needed.
  • Provide support, guidance, data, and analysis to other departments.
  • Drive improvements in product and process quality and identify and escalate quality non-conformances to support 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, facilitate or contribute to corrective and preventive actions, and contribute to quality key performance indicators and the journey to 5 Sigma.
  • Identify and evaluate procedures to ensure production of quality products in manufacturing.
  • Use measurement tools to ensure products meet standards before release.
  • Conduct studies to understand process and/or measurement-system capability.
  • Perform dimensional testing of products before and after cleaning.
  • Provide technical support to the Quality group as required.
  • Decide how to handle product issues with operators and whether products are acceptable.
  • Write technical reports, records of standards and rejections, and other required quality documentation as needed.

Desired Qualifications

  • An associate degree or experience in the area of technical expertise.
  • Understanding of ISO 9001 and ISO 13485 quality standards.
  • Product knowledge.

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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