What are the responsibilities and job description for the Senior Quality Assurance Manager position at Tecomet, Inc?
Use your strong leadership abilities and expertise in both Quality and Regulatory to lead and direct Quality Assurance and Regulatory Affairs Systems for our Kenosha site dedicated to manufacturing complex instrumentation for the spine, orthopedics, ligation and sports medicine markets with a focus on Tecomet owned products/ You will deliver improvements and sustaining activities for operations. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements. Create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations for $40 million in annual sales. Experience to set you up for success in the role include:
- Bachelor of Science in Engineering
- 5 years of Quality Engineering experience within a manufacturing environment
- 2 years of experience related to working within a regulated environment is preferred.
- 3 years working directly with New Product Development and/or related launches
- ISO 13485/EN46001
- ISO 14001
- Federal and State laws and regulations
- Knowledge of International Quality Standards
Salary : $40
