Quality Control Inspector

Inspection
Scottsdale, AZ
Posted 3 weeks ago

The QC Inspector performs sampling, inspection, testing, and sampling of incoming materials; conducts required in-process and final inspection of reprocessed devices their packaging; performs pre- and post-sterilization inspection of batches and review of Batch Production Records (BHRs). Strictly follows and enforces established procedures and policies needed to meet the demands of Quality in a regulated medical device company.

Essential Duties and Responsibilities:

  • Perform inspections of purchased components, reprocessed devices and their packaging, sterilization records, and Batch History Records (BHRs) to controlled procedures and pre-determined acceptance criteria.
  • Accurately document the results of the inspections and testing.
  • Participate in the creation and/or revision of procedures for the inspection function.
  • Ensures appropriate labeling, storage and handling of product and materials throughout the manufacturing facility to prevent mix-ups.
  • Ensures Quarantine areas are orderly maintained and scrapping requests made by the Materials Review Board (MRB) are fulfilled.
  • Responsible for updating material status in ERP system following the completion of Quality activities.
  • Ensures line clearance and material reconciliation activities are conducted as dictated by company procedures.
  • Assist with nonconforming product investigations, CAPAs, and customer complaints.
  • All other reasonable duties, as assigned.

Education, Qualifications and Skills:

  • High School Diploma or equivalent; 1-2 years of Quality Inspection experience is preferred.
  • Must have good English written and verbal communication skills; Good arithmetic skills are required
  • Mechanical aptitude and working knowledge of measure instruments is desired
  • Experience with 21CFR820, Quality Systems Regulation and ISO 13495 a plus.
  • Must demonstrate a high level of attention to detail in completion of tasks and cross-referencing of information in several locations.
  • Must demonstrate the ability to multi-task and prioritize in a fast-paced environment, and possess flexibility when juggling numerous projects simultaneously.
  • General proficiency in Microsoft Word and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
  • Experience with J.D. Edwards ERP software use a plus.
  • Must grasp instructions and information rapidly and apply them with little supervision self-motivated, self-starter.
  • Strong verbal, written, organizational, time management and interpersonal skills.

 

Job Features

Job CategoryQuality

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Misty Marshall

Misty Marshall

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