What are the responsibilities and job description for the Instrumentation Manufacturing QA Lead position at Tecomet, Inc?
Role Overview: The Senior Quality Assurance Manager will lead our Quality Assurance and Regulatory Affairs Systems for the development and manufacture of complex instrumentation. This includes creating, monitoring, and improving quality systems/programs to ensure compliance with FDA and ISO regulations.
- Main Responsibilities:
- Lead cross-functional teams to develop and implement process improvements.
- Reduce quality costs and improve operational efficiency.
- Ensure regulatory compliance and adherence to company policies.
- Qualifications and Experience:
- 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.
