Quality Control Inspector

About the role

We're looking for a Quality Control Inspector to join our mission-driven Quality team. In this role, you'll be responsible for performing inspections of components, subassemblies, and finished medical devices to ensure compliance with quality standards and regulatory requirements.

Responsibilities

• Conduct detailed inspections of purchased components, tooling, subassemblies, and finished products using established measurement techniques, ensuring all evaluations support safe and effective patient outcomes.
• Identify nonconforming materials and take appropriate action, including rework or rejection, maintaining a strong commitment to quality and accountability.
• Adhere to established procedures and systems, demonstrating consistency, integrity, and respect for standardized processes.
• Accurately document inspection and testing results in compliance with Good Documentation Practices (GDP), ensuring transparency and traceability.
• Maintain controlled documentation and test records with a high level of accuracy and timeliness.
• Inspect and support the maintenance and calibration of test equipment and fixtures to ensure reliable and precise performance.
• Review Device History Records and related documentation to verify compliance with procedures and documentation standards.
• Assess quality issues and contribute thoughtful recommendations for corrective actions and continuous improvement.
• Partner cross-functionally with quality and production teams to enhance assembly accuracy, compliance, and overall product excellence.
• Operate effectively within a cleanroom environment, following all protocols to maintain product integrity.
• Perform product testing to verify conformance to established quality standards and performance expectations.
• Demonstrate reliability, accountability, and a proactive approach to work, contributing positively to team goals and shared success.

Qualifications

• Education: AA degree or higher required.
• Experience: 3–6 years of Quality Control experience, in the medical device industry.
• Skills/Competencies: Mechanical aptitude and working knowledge of measurement instruments; proficiency in Microsoft Excel and Word; ability to read and interpret technical procedures, drawing, specifications, ASTM standards, and medical device regulatory requirements; strong written and verbal communication skills for reports, correspondence, and presentations; mathematical proficiency in probability, statistical inference, fractions, percentages, ratios, and proportions; problem-solving skills with the ability to work in a cross-functional environment and manage multiple priorities; experienced in using measuring equipment such as Microscope, CMM, Instron tester, calipers, pin gauge, micrometer, snap gauge etc.