Quality Lead - Medical

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

Job Description:ABOUT TTITechtronic Industries is a fast-growing world leader in Power Tools, Accessories, Hand Tools, Outdoor Power Equipment, and Floor Care for Do-It-Yourself (DIY), professional and industrial users in the home improvement, repair, maintenance, construction, and infrastructure industries. The Company is committed to accelerating the transformation of these industries through superior environmentally friendly cordless technology.JOB SUMMARYThis individual must interface with all members of Quality and Manufacturing daily to support FDA and ISO 13485 requirements as it pertains to incoming part inspection, documentation, and final release of finished goods. Responsible for interface with internal Supply Chain and external Suppliers as it relates to the approval of incoming parts; Manufacturing Assemblers as it relates to in-process assembly of medical devices. Requires daily contact with staff and middle management levels.RESPONSIBILITIES / SKILLSProactively 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.Leadership abilities to be able to train, develop, and motivate the Quality Control team.Be a contact point for the Quality Control team members.Assist the Quality Engineers in nonconforming process of defective parts and in-process units.Efficiently execute tasks and maintain quality by continuously monitoring processes and parts; provide immediate feedback with alternative options as necessary.EDUCATION AND EXPERIENCE5+ years of quality inspection experience in Medical Device or related field.Bachelor’s Degree or Associate's Degree with appropriate quality experience.Candidate must be a self-directed, detail-oriented, dependable, and trustworthy person who works well independently, while being highly motivated.Use prompt judgements and actions based on professionalism and experiences to find concrete and clear solutions.Experience in Quality inspection, sort, and containment.Knowledge of MS Office, including MS Excel, MS Word, and MS PowerPoint.Excellent communication skills: able to read and understand technical reports, specifications, and communicate clearly with the customer.Ability to interface with various levels of management, suppliers, and customers.Experience with SAP a plus.FDA 21 CFR 820 and ISO 13485 knowledge preferred.OTHER REQUIREMENTSCertification in a Quality discipline preferred, example CQIA, CQI, CQTPHYSICAL REQUIREMENTSJob requires both desk/computer work, and prolonged periods standing/moving on feet.Must be able to lift up to 30 pounds at times.