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
Develops validation strategies for installation, operations and performance qualifications for the Medical group. Develop protocols to analyze process changes or studies using appropriate statistical techniques. Creates quality assurance/control policies and procedures; conducts training on quality assurance/control concepts and tools; and interfaces with all other engineering components within the company and with customers and suppliers on quality related issues.
RESPONSIBILITIES / SKILLS
- Oversee the Nonconforming and Supplier Nonconforming Programs
- Maintain active calibration of equipment and tracking
- Maintain active preventive maintenance program
- Perform new equipment or new process validation activities
- Develop sampling strategies and perform appropriate statistical analysis of data
- Active in continuous improvement of all Quality Management Systems as it relates to Medical Devices
EDUCATION AND EXPERIENCE
- 3-5 years’ experience in an FDA/ISO regulated environment. Medical Device industry is preferred.
- Four-year college degree preferred; two-year college degree with 5-7+ 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.
- Knowledge in validations – IQ/OQ/PQ – as it pertains to Medical Devices.
- 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 required.
OTHER REQUIREMENTS
- Professional certifications through ASQ – CQE, CQA
- Experience with Minitab a plus
- Experience with SAP a plus
PHYSICAL REQUIREMENTS:
if applicable,
select one & change pounds
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 30 pounds at times.
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