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Integer Holdings Corporation

Medical device CDMO for cardiac devices

Quality Inspector 2

Inspection & TestConfirmed live in the last 24 hours
Full-timeAlden, NY, USAIn-person

About the Job

Requirements

  • Understanding of geometric dimensioning and tolerancing (GD&T).
  • Understanding of ISO 9001 and ISO 13485 quality standards is preferred.
  • Product knowledge is helpful.
  • IPC certification is preferred.
  • Computer operation skills, including Microsoft Office and Oracle Quality modules.
  • Ability to read and interpret sampling and inspection plans and engineering drawings.
  • Experience using measurement tools and hand gages to measure physical dimensions and other attributes, such as pin gages, calipers, optical comparators, SmartScope, and pull testers.
  • Experience measuring physical dimensions on parts.
  • Knowledge of tolerances.
  • Basic mathematics knowledge.
  • High school graduation or equivalent may be required.
  • One year of experience as a Quality Inspector or two years of related inspection experience in manufacturing may be required; some associate’s degrees may substitute for years of experience.
  • An associate’s degree or experience in inspection is preferred.

Responsibilities

  • Perform visual, dimensional, and/or functional inspections of raw materials, in-process assemblies, and finished products according to authorized specifications and applicable quality standards; identify and segregate nonconforming materials and initiate the nonconformance report process.
  • Use measurement tools, equipment, and hand gages to measure physical dimensions and other attributes, and ensure current calibration.
  • Recommend appropriate gages and other equipment for measuring products or parts.
  • Compile or complete quality records, reports, and documentation for product, material, and equipment inspection while applying Good Documentation Practices.
  • Understand and adhere to sampling plans.
  • Support material transactions in Oracle.
  • Participate in first article inspection processes.
  • Support process audits and provide feedback to manufacturing cells regarding quality findings.
  • Update certificates of conformance and analysis through customer portals or systems such as SQM and eCert.
  • Participate in problem solving and provide input for process and product evaluations for continuous improvement.
  • Expand skills through on-the-job training, cross-training, and classroom instruction.
  • Train personnel in proper inspection techniques, systems, equipment, and processes.
  • Provide support, guidance, data, and analysis to other departments.
  • Drive improvements in product and process quality and identify and escalate quality nonconformances 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.
  • Embed quality in daily work by assuring adherence to the quality management system, facilitating and/or contributing to corrective and preventive actions, and contributing to quality key performance indicators and the journey to 5 Sigma.
  • Assist the site in achieving annual goals for safety, quality, delivery, cost, and inventory.
  • Achieve assigned goals and objectives.

Desired Qualifications

  • Understanding of ISO 9001 and ISO 13485 quality standards.
  • Product knowledge.
  • IPC certification.
  • An associate’s degree or experience in inspection.

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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