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Senior Quality Engineer
Senior Quality EngineerZipRecruiter • Monroe, LA, US
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Senior Quality Engineer

Senior Quality Engineer

ZipRecruiter • Monroe, LA, US
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Overview

Supplier Quality Engineer $96k - $130k - Monroe, NC

H1B and TN Visa accepted

No C2C

A global leader in high-quality plastic laboratory products, their company specializes in developing innovative solutions for hospitals, laboratories, universities, research institutes, and the diagnostic, pharmaceutical, and biotechnology industries.

Responsibilities

  • Set detailed guidelines on inspection and testing requirements
  • Ensure products adhere to company and industry quality standards
  • Develop inspection methods to analyze product quality
  • Identify and lead CAPA and process improvement initiatives
  • Develop, maintain, and monitor measurement processes to ensure compliance with ISO and FDA regulations
  • Collaborate with suppliers to investigate root cause and corrective actions when raw material or component deficiencies are detected
  • Monitor and evaluate supplier processes for compliance with purchase order and engineering requirements
  • Deploy variation management tools and techniques at select suppliers to mitigate risk
  • Audit suppliers and establish supplier quality requirements
  • Report on supplier trends for management review and notify management of identified trends
  • Design and implement methods for process control, process improvement, testing, and inspection
  • Establish and maintain process flow diagrams, workplace layouts, FMEAs, and standardized work instructions

Qualifications

  • Bachelor's degree in an engineering field or related field. Master's degree in engineering is
  • 3-7 years of experience in a high-volume regulated manufacturing industry in an engineering field
  • Working experience with Six Sigma, Lean, and Quality Management Tools
  • Broad knowledge of theory and principles of statistics and statistical process control
  • Experience with Access Database, Excel, and complaint handling software
  • In-depth knowledge of ISO 13485, ISO 14971, and CFR Part 820
  • Good understanding of medical device regulation, industry, and international standards
  • Strong computer skills in MS Office
  • Ability to recognize and manage projects
  • Ability to read and understand technical drawings and documents
  • Working experience with CAD / SolidWorks
  • Ability to work independently and take initiative
  • Excellent communication, analytical, troubleshooting, and interpersonal skills
  • ASQ Lead Auditor or equivalent training in auditing
  • A team player with the ability to work independently
  • J-18808-Ljbffr

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    Senior Quality Engineer • Monroe, LA, US

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