Cadence Inc
Quality Technician II - Critical Medical Components/Devices
Cadence Inc, Cranberry Twp, Pennsylvania, United States, 16066
Quality Technician - Critical Medical Devices
About the Role:
As a Quality Technician, you'll be responsible for performing detailed inspections and functional tests on critical components and/or finished medical devices. This role is focused on inspection and testing-requiring precision, consistency, and a solid understanding of medical device standards. You'll work closely with Quality Engineers and Production to proactively identify gaps to compliance, verify documentation, and support continuous improvement. This position will play a very active role on the floor in support of daily operations and manufacturing execution.
This role will support our growth on our 2nd shift and will work Monday through Friday, 4:30pm-3am. (4-10 hour shifts)
Key Responsibilities: Perform dimensional and visual inspections on critical medical device components or assemblies using various measurement tools like calipers, micrometers, vision inspection equipment, gauges, etc. Conduct functional tests and verify conformance to detailed specifications and tolerances Interpret engineering drawings, specifications, and work instructions Record and maintain accurate inspection data, including lot history and traceability records Support lot release, material review, and root cause analysis for nonconforming parts Participate in audits and provide complete, well-organized inspection documentation Assist in implementing corrective actions and reinforcing compliance with ISO 13485 and FDA regulations Ensuring adherence to GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices) requirements Nonconformance, CAPA, and Material Review Board Support What You Bring:
Minimum 3-5 years of quality technical experience in the medical device industry required. Proven experience inspecting critical or high-precision components and/or devices. Familiarity with ISO 13485, and Good Documentation Practices (GDP) Proficiency with inspection equipment and interpreting engineering drawings and GD&T Experience using Excel, electronic QMS platforms (e.g., Minitab, ETQ, Master Control), and document control systems Excellent attention to detail, organization, and communication skills Preferred Qualifications:
CQI or CQT certification Experience with cleanroom manufacturing in a medical device setting. Working knowledge of SPC and data analysis tools such as Minitab Familiarity with Failure Investigation techniques.
Why This Role Matters: This isn't just another inspection job-you'll be directly responsible for ensuring the integrity of a component essential to patient outcomes. Your work will help ensure that only the highest-quality components and devices are released for assembly and use in the field.
About the Role:
As a Quality Technician, you'll be responsible for performing detailed inspections and functional tests on critical components and/or finished medical devices. This role is focused on inspection and testing-requiring precision, consistency, and a solid understanding of medical device standards. You'll work closely with Quality Engineers and Production to proactively identify gaps to compliance, verify documentation, and support continuous improvement. This position will play a very active role on the floor in support of daily operations and manufacturing execution.
This role will support our growth on our 2nd shift and will work Monday through Friday, 4:30pm-3am. (4-10 hour shifts)
Key Responsibilities: Perform dimensional and visual inspections on critical medical device components or assemblies using various measurement tools like calipers, micrometers, vision inspection equipment, gauges, etc. Conduct functional tests and verify conformance to detailed specifications and tolerances Interpret engineering drawings, specifications, and work instructions Record and maintain accurate inspection data, including lot history and traceability records Support lot release, material review, and root cause analysis for nonconforming parts Participate in audits and provide complete, well-organized inspection documentation Assist in implementing corrective actions and reinforcing compliance with ISO 13485 and FDA regulations Ensuring adherence to GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices) requirements Nonconformance, CAPA, and Material Review Board Support What You Bring:
Minimum 3-5 years of quality technical experience in the medical device industry required. Proven experience inspecting critical or high-precision components and/or devices. Familiarity with ISO 13485, and Good Documentation Practices (GDP) Proficiency with inspection equipment and interpreting engineering drawings and GD&T Experience using Excel, electronic QMS platforms (e.g., Minitab, ETQ, Master Control), and document control systems Excellent attention to detail, organization, and communication skills Preferred Qualifications:
CQI or CQT certification Experience with cleanroom manufacturing in a medical device setting. Working knowledge of SPC and data analysis tools such as Minitab Familiarity with Failure Investigation techniques.
Why This Role Matters: This isn't just another inspection job-you'll be directly responsible for ensuring the integrity of a component essential to patient outcomes. Your work will help ensure that only the highest-quality components and devices are released for assembly and use in the field.