Senior Quality Lead – Medical Devices (ISO 13485, FDA)

Techtronic Industries Power Equipment; Anderson (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

TTI Techtronic Industries in Anderson, SC seeks a seasoned Quality Inspector to ensure FDA and ISO 13485 compliance. You will partner with Quality and Manufacturing daily on incoming part inspection, documentation, and final release of finished goods, and coordinate with suppliers on part approvals.

The ideal candidate has 5+ years in medical device quality, a Bachelor’s or Associate degree, and hands-on experience with SAP and MS Office.

Qualifications

• 5+ years of quality inspection experience in medical device or related field.
• Bachelor’s or Associate degree with appropriate quality experience.
• Experience with FDA 21 CFR 820 and ISO 13485 knowledge preferred.

Responsibilities

• Proactively ensure smooth team operations and effective collaboration as it relates to the performance of incoming receipt, inspection, and release of purchased parts and materials to Production.
• Manage the Finished Product Release process – document review, product release, and Certificate of Conformance creation.
• Be a contact point for the Quality Control team and assist with nonconforming parts and in-process units.
• Interface with internal Supply Chain and external Suppliers as it relates to approval of incoming parts.

Skills

Quality inspection

FDA 21 CFR 820 knowledge

ISO 13485 knowledge

Supplier interface

Education

Bachelor’s or Associate degree in quality

Tools

SAP

Microsoft Office

Job description

TTI Techtronic Industries in Anderson, SC seeks a seasoned Quality Inspector to ensure FDA and ISO 13485 compliance. You will partner with Quality and Manufacturing daily on incoming part inspection, documentation, and final release of finished goods, and coordinate with suppliers on part approvals.

The ideal candidate has 5+ years in medical device quality, a Bachelor’s or Associate degree, and hands-on experience with SAP and MS Office.