What are the responsibilities and job description for the Senior Quality Assurance Director position at Tecomet, Inc?
Company Overview
Tecomet, Inc is a leading manufacturer of complex instrumentation for the spine, orthopedics, ligation, and sports medicine markets.
About the Role
We are seeking a highly skilled Senior Quality Assurance Manager to lead and direct our Quality Assurance and Regulatory Affairs Systems.
Key Responsibilities
- Lead and direct Quality Assurance and Regulatory Affairs Systems for Tecomet's Kenosha site.
- Deliver improvements and sustaining activities for operations.
- Ensure patient and employee safety and achievement of customer quality requirements.
- Create, monitor, and improve quality systems/programs.
- Maintain compliance within FDA and ISO regulations.
Requirements
- 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 preferred.
- 3 years working directly with New Product Development and/or related launches.
- ISO 13485/EN46001 certifications.
- Knowledge of International Quality Standards.
What We Offer
A competitive salary and benefits package, as well as opportunities for career growth and professional development.
