Medical Device QA Lead — FDA/ISO 13485 Expert

Techtronic Industries; Anderson (SC); On-site; USD 70,000 - 95,000; Full time

Job summary

Techtronic Industries is seeking a Quality Inspector/Lead to support FDA and ISO 13485 requirements for incoming part inspection, documentation, and final release of finished goods. The role interfaces with Quality, Manufacturing, Supply Chain, and external suppliers to ensure compliant part approvals.

Responsibilities include ensuring smooth operations for incoming receipts, managing the finished product release process, and training the QC team.

Qualifications

• Must have 5+ years of quality inspection experience in Medical Device or related field.
• Excellent communication and documentation skills, ability to read and interpret technical reports.

Responsibilities

• Ensure smooth team operations for incoming receipt, inspection, and release of purchased parts and materials to Production.
• Manage Finished Product Release process: document review, product release, and Certificate of Conformance creation.
• Train, develop, and motivate the Quality Control team and serve as a contact point for QC staff.
• Assist Quality Engineers with nonconforming parts and in-process unit issues; provide immediate feedback and alternatives.

Skills

Attention to detail

Communication

Leadership

Education

Bachelor's/Associate degree in related quality field

Tools

MS Office

SAP

Job description

Techtronic Industries is seeking a Quality Inspector/Lead to support FDA and ISO 13485 requirements for incoming part inspection, documentation, and final release of finished goods. The role interfaces with Quality, Manufacturing, Supply Chain, and external suppliers to ensure compliant part approvals.

Responsibilities include ensuring smooth operations for incoming receipts, managing the finished product release process, and training the QC team.