Quality Lead - Medical

TTI Consumer Power Tools, Inc.; United States; On-site; USD 80,000 - 105,000; Full time

Job summary

TTI Consumer Power Tools, Inc. seeks a seasoned Quality Inspector to support FDA and ISO 13485 compliance in incoming part inspection, documentation, and final release of finished goods.

You will interface with Supply Chain, Suppliers, and Manufacturing Assemblers while working with middle management daily. The role requires 5+ years in medical device quality inspection, a Bachelor’s or Associate’s degree, and strong communication.

Qualifications

• 5+ years of quality inspection experience in Medical Device or related field.
• Bachelor’s Degree or Associate's Degree with appropriate quality experience.
• Excellent communication skills: able to read and understand technical reports, specifications, and communicate clearly with the customer.
• Experience with FDA 21 CFR 820 and ISO 13485 knowledge preferred.
• Experience with SAP a plus.

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.
• Leadership abilities 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 monitoring processes and parts; provide immediate feedback with alternative options as necessary.

Skills

Quality inspection

Leadership

Communication

Self-directed

Education

Bachelor’s Degree

Associate's Degree

Tools

MS Office

Excel

Word

PowerPoint

SAP

Job description

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.

ABOUT TTI

TTI is a world-class leader in design, manufacturing and marketing of Power Tools, Hand Tools, Outdoor Power Equipment, and Floor Care and Appliances for consumers, professional and industrial users in the home improvement, repair and construction industries. Our unrelenting strategic focus on Powerful Brands, Innovative Products, Operational Excellence and Exceptional People drives our culture. TTI was founded by Mr. Horst Julius Pudwill and Prof. Roy Chi Ping Chung BBS JP in 1985, yet the history of TTI's unique and growing portfolio of world-famous brands stretches back at least one hundred and fifty years. Through a clear and consistent strategy of acquiring and developing established brands, TTI has grown to become a clear market leader in power tools, outdoor power equipment, hand tools and floor care appliances worldwide. TTI is proud of its own history, and proud, too, of the huge legacy of tradition and excellence that we have inherited from the brands that make up our Company today. TTI actively promotes a strong corporate culture of respect and ethical integrity. Our Values are our beliefs, principles and standards that do not change over time. Values are the resources we draw on when asked to make decisions. They form the groundwork for our ethical behavior. All that we do at TTI must be consistent with the values to which we subscribe.