Job Title: Quality Technician

Location: Sturgeon Bay, WI

Duration: 6 months

Company: Plastics Medical Manufacturing/Assembly

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

Requirements:

- 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.