Job Description
Job Description
Title: Quality Inspector
Industry: Medical Device
Location: Franklin, Massachusetts
Duration: 6 months
Responsibilities:
- Perform inspections and functional testing of components, sub-assemblies, and finished devices in accordance with approved procedures
- Prioritize workload and manage daily inspection activities with minimal supervision
- Maintain inspection logs, worksheets, device history records, and other controlled documentation
- Execute material and SAP transactions as required
- Complete final labeling and packaging of finished goods
- Enter QC inspection results into Excel and SAP
- Ensure Good Documentation Practices across all controlled records
- Support archiving activities for digital storage of records
- Review quality, repair, inspection, and device history documentation
- Approve and release finished product for shipment
- Adhere to FDA Quality System Regulations, ISO 13485, and company quality policies
- Maintain compliance with environmental, health, and safety regulations, including ISO 14001
- Report safety risks or potential violations as required
- Ensure personal ability to safely perform job duties
Requirements:
- High school diploma or equivalent
- 0–1 year of experience in manufacturing, assembly, or quality control inspection
- Ability to read and interpret engineering drawings and procedures
- Knowledge of basic mechanical measurement tools; microscope experience preferred
- Experience working with medical devices and QSR/ISO standards is a plus
- Computer proficiency with data entry experience; Excel required, SAP preferred
- Strong communication skills; ability to escalate nonconformances appropriately
- Ability to collaborate effectively and maintain professional working relationships
- Adaptable with the ability to manage shifting priorities
Physical Requirements
- Visual acuity of 20/25 or better (with or without correction)
- Ability to lift up to 50 lbs; occasionally up to 70 lbs with assistance
- Ability to work overtime as needed
- Reliable attendance and punctuality
- May require extended standing and microscope work
- Standard controlled room environment
Hourly rate is commensurate with experience and is an estimated range provided by WorkGenius.