Quality Inspector

About the role

The Quality Inspector supports the Value Stream by performing inspections of incoming, in‑process, and finished goods, and is responsible for preparing and releasing surgical sterile loads while ensuring compliance with FDA QMSR and ISO 13485 requirements.

Key responsibilities

• Perform visual and dimensional inspections of materials, including incoming, in‑process assemblies and finished goods using calipers, micrometers, microscopes and visual measurement systems.
• Assist with calibration coordination, ensure equipment is calibrated, and address out‑of‑calibration issues.
• Verify production records for completeness, prepare and release sterile products, and manage raw material and finished‑goods releases in the ERP system.
• Segregate, quarantine, and re‑inspect rejected or quarantined materials, completing all required documentation.
• Collaborate with engineers, operators, production, and purchasing to resolve quality issues and maintain accurate device history records.

Required profile

• Associate’s degree or equivalent experience.
• 3+ years of quality inspection experience, preferably in a medical‑device environment.
• Ability to lift 20 pounds.

Required skills

• Proficiency with inspection equipment: calipers, micrometers, microscopes, visual measurement systems.
• Working knowledge of ERP systems, Trackwise, Lotus Notes, and Microsoft Office.
• Understanding of QSR/ISO 13485 documentation requirements.

What we offer

• Comprehensive medical, dental and vision insurance, plus wellness and mental‑health resources.
• Competitive 401(k) plan with immediate company match.
• Generous paid time off, flexible work hours and hybrid work options.
• Professional development through training, mentorship and tuition reimbursement.
• Hourly rate of $25–$30 with potential bonuses and incentives.