Quality Technician II - Medical

TTI Consumer Power Tools, Inc.; United States; On-site; USD 55,000 - 75,000; Full time

Job summary

TTI Techtronic Industries is seeking a detail-oriented Quality Inspector to support FDA and ISO 13485 compliance for incoming parts and documentation. The role interfaces with Quality, Manufacturing, and Supply Chain to ensure compliant parts and proper records for medical devices.

Responsibilities include incoming receipt, inspection, release of purchased parts, nonconforming part handling, device history records review, and collaboration with engineers and assemblers to maintain product

Qualifications

• 2-4 years of quality inspection experience.
• High School Diploma or equivalent; an Associate's or Bachelor's degree is a plus.
• Proficient in MS Office (Excel, Word, PowerPoint).
• Ability to read and interpret technical reports and specifications.
• Must be detail-oriented, dependable, and a team player.

Responsibilities

• Perform incoming receipt, inspection, and release of purchased parts and materials.
• Assist in nonconforming process of defective parts.
• Perform required manufacturing line clearance activities to verify parts and equipment prior to assembly.
• Perform required document review (Device History Record) of medical devices.
• Assist with in-process nonconforming and complaint reviews as assigned.
• Performs other duties as assigned.

Skills

Detail-oriented

Team player

Excellent communication

Education

High School Diploma or equivalent

Associates/Bachelor's degree preferred

Tools

MS Office (Excel, Word, PowerPoint)

SAP experience a plus

Job description

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. At TTI Anderson, our brands RYOBI and HART are recognized worldwide for their deep heritage and cordless product platforms of superior quality, outstanding performance, safety, productivity, and compelling innovation.

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 and documentation. Responsible for interface with internal Supply Chain 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

• Perform incoming receipt, inspection, and release of purchased parts and materials.
• Assist in nonconforming process of defective parts.
• Perform required manufacturing line clearance activities to verify parts, and equipment prior to assembly.
• Perform required document review (Device History Record) of medical devices.
• Assist with in-process nonconforming and complaint reviews as assigned.
• Performs other duties as assigned.

EDUCATION AND EXPERIENCE

2-4 years of quality inspection experience. High School Diploma or equivalent. Additional college level courses towards an Associates or Bachelor’s Degree is a plus. Candidate must be a detail-oriented, dependable, and trustworthy person who works well as part of a team. 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.

OTHER REQUIREMENTS

• Knowledge of inspection techniques and Quality Systems is a plus.
• FDA 21 CFR 820 and ISO 13485 knowledge preferred.
• Experience with SAP a plus.

PHYSICAL REQUIREMENTS

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 30 pounds at times.

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.