Quality Assurance Engineer

2 weeks ago


Longmont, Colorado, United States International Staff Consulting Full time

Quality Engineer Job Overview:
As a Quality Engineer at International Staff Consulting, you will collaborate with the team to enhance the quality of our operations and deliverables.

Your role will involve establishing quality benchmarks, formulating quality assurance systems, and guiding cross-departmental teams in resolving issues, leading to effective and innovative corrective measures.

An ideal candidate for this position should possess exceptional problem-solving abilities and a strong commitment to ensuring that our processes and products consistently fulfill customer expectations and adhere to all regulatory guidelines.


Key Responsibilities of the Quality Engineer:

  • Establishing and executing quality benchmarks and systems while monitoring and evaluating quality performance, with a solid understanding of statistical controls.

Knowledge of Regulatory Standards:
ISO13485, AS9100, ITAR, 21 CFR Part 11, REACH/RoHS, CMRT,
Familiarity with Quality Tools: 5 Whys, Fishbone Diagram, APQP, PPAP, PFMEA, SPC, MSA,

  • Working alongside operations to create and implement controls and enhancements.
  • Ensuring that workflows, processes, and products meet customer and regulatory standards.
  • Leading the investigation and resolution of product or production challenges.
  • Driving corrective action initiatives, solutions, and ongoing improvements.
  • Acting as the primary contact for quality-related customer inquiries and managing scorecard feedback on quality.
  • Conducting customer and internal audits, and supporting external audit processes.
  • Managing supplier-related issues, including issuing Supplier Corrective Actions and ensuring follow-up.
  • Serving as the Quality Representative during MRB and New Product Introductions.
  • Overseeing document control responsibilities.
  • Managing supplier relations, including the Approved Vendor List and overseeing regulatory and certification updates.

Qualifications for the Quality Engineer:

  • A minimum of 5 years of experience in Quality Engineering within the medical manufacturing sector.
  • A bachelor's degree in engineering or a related technical field.
  • Possession of an active ISO13485 Lead Auditor certification.
  • Strong knowledge of GD&T.
  • Proficiency in Microsoft Word, Excel, and PowerPoint.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving capabilities.
  • Self-motivated, inquisitive, and results-oriented.


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