Quality Technician II - 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. 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: