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Integer Holdings Corporation

Medical device CDMO for cardiac devices

Quality Inspector 3

Inspection & TestConfirmed live in the last 24 hours
Full-timeBedford, MA, 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.
  • IPC certification may be required.
  • Strong 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.
  • Demonstrated experience measuring physical dimensions on parts.
  • Strong applied knowledge of tolerances.
  • Strong general mathematics skills.
  • Four years of work experience as a Quality Inspector or five years of related inspection experience in manufacturing may be required; some associate's degrees may substitute for years of experience.
  • High school graduation or equivalent may be required; an associate's degree or inspection experience is preferred.

Responsibilities

  • Perform visual, dimensional, and/or functional inspections of raw materials, in-process assemblies, and finished products in accordance with authorized specifications and applicable quality standards; identify and segregate non-conforming materials and initiate the nonconformance reporting (NCR) process.
  • Use measurement tools, equipment, and hand gages to measure physical dimensions and other attributes, and ensure current calibration.
  • Compile or complete quality records, reports, and documentation for product, material, and equipment inspections while applying Good Documentation Practices (GDP).
  • Recommend appropriate gages and other equipment for measuring products or parts.
  • 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 regarding quality findings.
  • Participate in problem solving and provide input for process and product evaluations for continuous improvement; support investigations and help implement corrective actions.
  • Generate trends of non-conforming material and assist Quality with NCR metrics analysis.
  • Manage and program automatic coordinate measuring machines (CMM) or Seebrez inspection equipment, if applicable.
  • Monitor Dock to Stock programs, if applicable.
  • 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 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 (QMS); assure adherence to the QMS, facilitate and/or contribute to corrective and preventive actions, and contribute 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.
  • Perform other duties as assigned.

Desired Qualifications

  • Product knowledge is helpful.

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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