Job Description

Job Description:

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

Participate in validation strategies for installation, operations and performance qualifications for the Medical group. Be main point of contact for part measurement analysis and compiling of data. Be able to support process changes or studies using appropriate statistical techniques. Willingness to interface with all other engineering components within the company and with customers and suppliers on quality related issues.

RESPONSIBILITIES / SKILLS

• Provide support to other members of the Quality Engineering team.
• Help maintain the Nonconforming and Supplier Nonconforming Programs.
• Participate in the calibration of equipment and tracking program.
• Participate in the preventive maintenance program.
• Actively participate in new equipment or new process validation activities.
• Document inspection results in accordance with the appropriate Quality Procedures.
• Perform appropriate statistical analysis of data.
• Active in continuous improvement of all Quality Management Systems as it relates to Medical Devices.

EDUCATION AND EXPERIENCE

• 0-4 years’ experience in an FDA/ISO regulated environment. Medical Device industry is preferred.
• Four-year college degree preferred; two-year college degree with 5+ years of relevant industry experience.
• Candidate must be a self-directed, detail-oriented, dependable, and trustworthy person who works well independently, while being highly motivated.
• Experience in writing and performing validations – IQ/OQ/PQ – as it pertains to Medical Devices.
• Familiarity with metric measuring instruments (e.g., calipers, micrometers).
• Knowledge of MS Office, including MS Excel, MS Word, and MS PowerPoint.
• Excellent communication skills: able to read and understand technical reports, specifications, and 2D part drawings.
• Ability to interface with various levels of management and customers.
• FDA 21 CFR 820 and ISO 13485 knowledge.

OTHER REQUIREMENTS

• Professional certifications a plus
• Experience with Minitab a plus
• 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