Quality Technician

Summary

The Quality Assurance (QA) Technician performs laboratory testing and quality control activities to support protocols, process qualification/certification, supplier approval, and new product introduction. The role executes validated/approved test methods, ensures data integrity and traceability in line with Good Documentation Practices (GDP), and partners with Engineering, Manufacturing, Supply Chain, Quality, and R&D to enable timely, compliant product release and continuous improvement.

Responsibilities

• Plan and perform laboratory testing of materials and products per approved methods to support protocols, process control/qualification studies, and new product approval.
• Record, analyze, and report results with accuracy and completeness; escalate nonconformances and support investigations as required.
• Support validation/qualification activities for new or modified equipment and processes in accordance with procedures.
• Conduct audits/inspections of products from external suppliers and compile clear, actionable reports.
• Calibrate or coordinate calibration of laboratory equipment; maintain calibration and maintenance records.
• Perform machine waste/defect analysis; collaborate with cross‑functional teams to identify root causes and recommend corrective actions to reduce scrap and rework.
• Compile release documentation for finished products and support product disposition activities in line with procedures.
• Apply Good Documentation Practices (GDP) in reviewing production and test records for accuracy and completeness.
• Contribute to standard operating procedures (SOPs), work instructions, and training materials; share knowledge with peers.
• Maintain a safe and compliant laboratory environment; follow EHS and quality system requirements.
• Other duties as assigned.
• Perform visual and dimensional inspections and laboratory tests using computerized test equipment and standard tools.
• Read and interpret procedures, specifications, and test methods; communicate clearly in writing and verbally.
• Operate office and laboratory equipment; perform keyboard‑intensive work; maintain accuracy and focus during repetitive tasks.
• Work independently and collaboratively to meet priorities and timelines; typical travel requirement: none.

Essential Functions of the Role

• Inspect goods for damage or discrepancies and report issues promptly.
• Conduct audits and inspections (internal and supplier).
• Maintain scientific and regulatory compliance in all clinical communications.

Education & Work Requirements

• Relevant Degree with 2-4 years of related experience

Education & Work Preferences

• Post‑secondary qualification (certificate, diploma, or degree) in a scientific or engineering discipline.
• Typically 2-3 years of relevant experience in quality, manufacturing, or laboratory environments, including at least 2 years of hands‑on laboratory testing experience.
• Proficiency using computerized laboratory test equipment and basic computer applications; ability to follow SOPs and apply GDP.
• Strong attention to detail, organization, and problem‑solving skills; ability to manage multiple tasks 
• Experience in medical device or other regulated manufacturing environments and exposure to validation activities.
• Familiarity with quality systems and tools (e.g., ISO 13485, GMP, SPC, CAPA, Minitab/other statistical tools).
• Experience supporting supplier/product audits and continuous improvement (e.g., Lean/5S).