Medical Device Quality Technician

Job Description

Job Description

Duties & Key Responsibilities
• Support manufacturing and testing operations in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) for receiving and inspection.
• Perform job duties in accordance with Global and Technical Standards and Quality System (QS) requirements.
• Complete Tier 1 inspections per inspection plans and drawings to support production schedules.
o Use hand tools (calipers, gauges, rulers) and perform visual inspections on inbound materials for medical device assembly.
o May operate more advanced measuring instruments as needed.
• Perform visual and dimensional inspections of cable harness assemblies and printed circuit board assemblies.
• Maintain accurate inspection records, documentation, and filing systems to meet GMP and quality compliance.
• Accept or reject supplier lots based on inspection results.
• Document any non conformances related to specifications, procedures, or standards, including completing required paperwork and system transactions.
• Initiate discrepant material reports and participate in data collection, analysis, and trending.
• Recommend improvements to policies, processes, and procedures.
• Perform moderately complex assignments, applying established methods to recurring situations; escalate more complex issues to senior quality personnel.
• Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory initiatives.
• Ensure adherence to all FDA, ISO, environmental, health, and safety requirements.

________________________________________

Key Skills
• Ability to perform accurate visual and dimensional inspections.
• Knowledge of GMP, GLP, and quality system regulations.
• Strong documentation and record keeping skills.
• Ability to analyze inspection data and identify trends.
• Attention to detail and accuracy.
• Ability to follow standards, procedures, and regulatory guidelines.
• Basic problem solving and initiative to complete tasks independently.

____________________________________________________________________________________________

Required Experience
• 0–2 years performing incoming dimensional inspections.
• Experience with hand measurement tools such as calipers, gauges, and rulers.
• Work experience supporting manufacturing or quality environments preferred.
• Intern will be considered

________________________________________
Preferred Experience (Nice to Have)
• Bachelor’s degree or technical diploma (not required but preferred if no prior inspection experience).
• Familiarity with medical device manufacturing or regulated environments.
• Experience reviewing engineering drawings, specifications, and inspection plans (required)