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Quality Assurance Engineer

2 months ago

St Louis, Missouri, United States Breakaway Consultants Full time
Job Overview

Are you dedicated to maintaining exceptional standards in product quality? Our client is seeking a Quality Assurance Engineer.

Position Summary

In the role of Quality Assurance Engineer, you will be responsible for ensuring that medical devices, materials, components, and manufacturing processes yield superior products. You will devise and implement strategies for inspecting, testing, and assessing product reliability.

Core Responsibilities

  • Quality Control: Guarantee that materials and processes yield top-quality products.
  • Testing & Evaluation: Establish inspection criteria and confirm compliance with specifications.
  • Methodology Development: Formulate sampling, inspection, and testing methodologies utilizing statistical tools.
  • Team Collaboration: Incorporate quality considerations into manufacturing processes and training programs.
  • Equipment Oversight: Manage and coordinate the calibration of equipment.
  • Client Engagement: Contribute to customer specifications and risk assessments.
  • Leadership: Guide teams in resolving quality concerns and overseeing the CAPA program.
  • Training: Educate members of the quality assurance team.
  • Communication: Engage with clients to support quality objectives.

Qualifications

  • Education: Bachelor’s degree in a scientific or engineering discipline.
  • Experience: Minimum of 3 years in a quality engineering position within the medical device sector or a related field.
  • Regulatory Expertise: Familiarity with Quality Management Systems (ISO 9001, ISO 13485, FDA QSR, cGMP 21 CFR Part 820).
  • Technical Proficiency: Skilled in Microsoft Office and database management; knowledge of SolidWorks or 3D CAD is advantageous.
  • Communication Skills: Strong written and verbal communication abilities in English.
  • Analytical Abilities: Excellent problem-solving and decision-making skills.
  • Certifications: Six Sigma, CQE, or CQA certifications are preferred.

Why Consider This Opportunity?

Our client provides a collaborative and innovative atmosphere where your contributions are recognized. You will lead important quality initiatives and collaborate with a dedicated team focused on excellence.