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Quality Assurance Specialist

2 months ago

Frederick, Colorado, United States Oculus Search Partners LLC Full time
Job Overview

Oculus Search Partners LLC is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Engineer, you will play a critical role in ensuring the quality of our medical devices meets the highest standards.

Key Responsibilities
  • Develop and implement quality standards and systems to ensure compliance with regulatory requirements.
  • Monitor and analyze quality performance using statistical controls and quality tools such as 5why, fishbone, APQP, and SPC.
  • Collaborate with operations to develop and implement controls and improvements to ensure workflows, processes, and products meet customer and regulatory requirements.
  • Lead the investigation and troubleshooting of product or production issues, and drive corrective action efforts to continually improve quality.
  • Act as the customer contact for quality issues and owner of scorecard feedback on quality.
  • Conduct customer audits, internal audits, and assist with external audits to ensure compliance with regulatory requirements.
  • Manage supplier issues, including issuing Supplier Corrective Actions and follow-through.
  • Serve as the Quality Representative at MRB and Product Launches for NPI.
  • Maintain document control and oversee supplier management, including the Approved Vendor List and managing regulatory and certification updates.
Requirements
  • Minimum of 5+ years of experience in Quality Engineering in the medical manufacturing industry, with experience in Class 2 or higher devices.
  • Bachelor's degree in engineering (or a technical degree).
  • Active ISO13485 Lead Auditor certificate.
  • Strong working knowledge of GD&T.
  • Proficiency in Microsoft Word, Excel, and PowerPoint.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Self-driven, curious, and motivated