Quality Assurance Specialist

Position Summary

The Quality Assurance Specialist is responsible for activities that support company quality objectives related to the production of advanced imaging systems. The QA Specialist supports the Quality System in ensuring compliance with ISO 13485 standards, 21 CFR 820 regulations and Canadian standards with a high degree of mechanical aptitude. Primary responsibilities include in-process and final product inspection, preparation of inspection reports, Device History Record (DHR) review and approval, support of Nonconforming Material Report (NCMR) disposition and Material Review Board (MRB) activities, and participation in internal and supplier audits.

• Comply with established company policies and procedures, objectives, quality assurance program, safety, and environmental standards.
• 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 will ensure consistently high quality.
• Collaborate with engineering teams to support investigation, containment, and execution for strategic quality issues.
• Adapt daily work activities to meet changing production schedules and quality priorities.
• Assist with maintaining quality performance metrics and identifying root causes of quality issues.
• Assist with Internal Audits and Supplier Audits according to regulations (FDA, ISO, Canada).
• 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.
• Provide support and/or maintenance of 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.
• Perform other duties as may be assigned.

• Associate’s Degree or Equivalent Years of or Military Experience
• 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

• 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.

• 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.

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

• Medical, Dental, Vision Insurance with HSA/FSA options
• Medical Coverage starting at $78.00 per pay for individual and increasing based on plan and dependent coverage options.
• Dental Coverage starting at $6.16 per pay for individual and increasing based on plan and dependent coverage options.
• Vision Coverage starting at $1.61 per pay for individual and increasing dependent coverage options.
• HSA plan with employer contribution, FSA Plan
• 401(k) with employer match
• Life Insurance, AD&D, Short-Term and Long-Term Disability Coverage
• Company provided $25,000 in Life Insurance with option to additional coverage.
• Additional supplemental insurances
• Employee Assistance Program
• Wellness Program
• Professional License fee reimbursement
• Paid Time Off – Including Vacation, Sick, and Holiday Time
• Employee Referral Program
• Tuition reimbursement