Quality Lead - Medical

Job Description:

ABOUT TTI

Techtronic 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 SUMMARY

This 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 / SKILLS

• 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.
• 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 EXPERIENCE

• 5+ 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 REQUIREMENTS

• Certification in a Quality discipline preferred, example CQIA, CQI, CQT

PHYSICAL REQUIREMENTS

• Job requires both desk/computer work, and prolonged periods standing/moving on feet.
• Must be able to lift up to 30 pounds at times.