Quality Assurance Specialist

About the role

The Quality Assurance Specialist supports company quality objectives related to the production of advanced imaging systems. The position adheres to ISO 13485 standards, 21 CFR 820 regulations, and Canadian standards, requiring a high degree of mechanical aptitude.

Responsibilities

• Inspect, diagnose, and document product and process quality issues to support repair and corrective actions.
• Work closely with manufacturing, process, and quality teams to establish processes and procedures that ensure consistently high quality.
• Collaborate with engineering teams to support investigation, containment, and execution for strategic quality issues.
• Audit manufacturing lines against released manufacturing processes and procedures.
• Assist in the identification and resolution of manufacturing quality issues, contain parts or products as needed, sort parts for quality requirements.
• Provide final inspection support and release of completed camera systems for shipment.
• Participate in continuous improvement activities, with manufacturing and external suppliers.
• Analyze and disposition component and product defects as a member of the Material Review Board.
• Conduct receiving and inspection activities to ensure compliance to released design specs and drawings.
• Support and/or maintain equipment calibration program.
• Prepare accurate inspection reports, quality documentation, and other written communications.
• Prioritize workload and adjust work assignments based on changing production and quality priorities.

Requirements

• Associates Degree or Equivalent
• Three or more years of experience directly related to Quality Assurance in a production environment
• Basic understanding of Quality Management Systems
• Ability to use Microsoft Operating Systems and QMS Programs

Preferred Qualifications

• Bachelor’s Degree in Engineering, Math, Science, or related discipline
• Experience in medical device manufacturing environment preferred
• Experience with electronics diagnostics
• Familiarity with medical device manufacturing, including the ability to read wiring diagrams and schematics

Physical Demands

• 15% Walking or Standing
• 85% Sitting
• Pushing, pulling, lifting up to 40 pounds
• Ability to see small items at a close distance, including judging spatial relationships to determine visual alignment and distinguishing colors

Working Conditions

Work is performed in a semi-quiet office or warehouse setting. The warehouse may be noisy at times.