Job Title: Medical Device Quality Inspector
Location: Madison, WI (Onsite)
Pay Rate: $30/hr. on W2
Job Summary
The Medical Device Quality Inspector is responsible for ensuring that materials, processes, and activities involved in daily device manufacturing, processing, and packaging meet current Good Manufacturing Practices (GMP) and comply with ISO 13485 and applicable quality standards. This position plays a key role in maintaining the quality integrity of medical device products through precise inspection and documentation.
Key Responsibilities
- Inspect parts according to engineering drawings and specifications.
- Perform dimensional inspections using precision tools such as calipers, micrometers, gage pins, plug gages, and thread gages.
- Record acceptance data in the SAP ERP system after inspection.
- Enter failure data into nonconforming material reports (NCMRs) when applicable.
- Support daily production activities and collaborate with the team to meet quality and output goals.
- Follow all established procedures in compliance with FDA and ISO 13485:2008 standards.
- Maintain documentation in accordance with GMP and company policies.
- Adapt to various inspection assignments and assist team members as needed.
- Work overtime when required based on production schedules and incoming part volumes.
Desired Experience
- Experience with optical measurement machines or a Coordinate Measuring Machine (CMM).
- Familiarity with ISO 13485 or ISO 9001 quality management systems.
- Prior experience with material or component inspection in a regulated environment preferred.
- Exposure to computer-based quality systems; SAP experience is a plus (training provided).
Qualifications
- Education: High School Diploma or equivalent.
- Language: Ability to read and write in English.
- Mathematical Skills: Basic math proficiency required.
- Technical Skills:
- Ability to use precision measurement tools such as calipers, micrometers, and thread gages.
- Proficiency with Microsoft Word and Excel.
- Soft Skills:
- Strong attention to detail and defect identification.
- Ability to work efficiently in a fast-paced team environment with minimal supervision.
- Flexibility to work overtime as required.
About the Role
This is a hands-on quality inspection position within a team-oriented environment that supports manufacturing operations. The ideal candidate is detail-oriented, computer-proficient, and eager to learn inspection procedures under regulated (FDA and ISO 13485) conditions.