What are the responsibilities and job description for the Quality and Regulatory Systems Director position at Tecomet, Inc?
About the Role: As a Senior Quality Assurance Manager at Tecomet, Inc., you will be responsible for leading our Quality Assurance and Regulatory Affairs Systems for the development and manufacture of complex instrumentation. This is a critical role that requires strong leadership abilities and expertise in both Quality and Regulatory.
- Your Key Accountabilities:
- Create, monitor, and improve quality systems/programs to ensure compliance with FDA and ISO regulations.
- Reduce quality costs and improve operational efficiency.
- Collaborate with cross-functional teams to develop and implement process improvements.
- What We Are Looking For:
- Bachelor of Science in Engineering or equivalent qualification.
- Minimum 5 years of experience in Quality Engineering within a manufacturing environment.
- Proven experience working within a regulated environment.
- Experience with New Product Development and/or related launches.
- Strong knowledge of quality management systems, including ISO 13485/EN46001 and ISO 14001.
- Knowledge of federal and state laws and regulations.
