What are the responsibilities and job description for the Regulatory Compliance Manager position at Custom Wire Technologies?
About Custom Wire Technologies
We are a leading OEM medical component manufacturer with a commitment to excellence and customer satisfaction. With over 50 years of experience in the industry, we offer a wide range of services including custom wire coiling, wire forming, custom grinding, fine wire welding, laser processing, and manufacturing process validation.
We are seeking a highly skilled and experienced Quality Engineer to join our team. As a Quality Engineer, you will be responsible for ensuring that our products meet the highest standards of quality and safety.
Key Responsibilities
The Quality Engineer will be responsible for:
- Developing and Implementing Quality Processes
- Validating Equipment and Products
- Supporting Product Development and Manufacturing
- Analyzing Quality Data
Develop, implement, and improve quality processes to ensure efficient and effective product quality control.
Validate equipment and products to ensure they meet the required quality standards.
Support the development and manufacturing of medical products, ensuring compliance with industry regulations.
Analyze quality data to identify trends and areas for improvement.
Requirements
To be successful in this role, you will need:
- Bachelor of Science degree - Engineering required
- 3 years related quality experience in ISO manufacturing environment, med tech and ISO 13485 experience preferred
- Strong knowledge and experience to perform validations and qualifications of products and processes
- Ability to analyze and interpret blueprints
- Proven experience with ability to manage multiple projects and meet deadlines
- Strong problem-solving skills and ability to perform root cause analysis
Our Benefits Package
We offer a comprehensive benefits package including medical, dental, vision, life and disability insurance, paid time off, 401(k) with company match, profit sharing, and paid holidays. If you are a motivated and experienced Quality Engineer looking for a new challenge, please apply today.
