Quality Lead - Medical Anderson, SC

Techtronic Industries; Anderson (SC); Presencial; USD 70 000 - 95 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Attention to detail

Communication

Leadership

Formação académica

Bachelor's/Associate degree in related quality field

Ferramentas

MS Office

SAP

Descrição da oferta de emprego

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.