What are the responsibilities and job description for the Quality Assurance Specialist position at Custom Wire Technologies?
Custom Wire Technologies
About Us:
We are a leading OEM medical component manufacturer with over 50 years of experience in the industry. Our services include custom wire coiling, grinding, forming, fine wire design, welding, laser processing, and manufacturing process validation.
Job Summary:
Under the direction of the Quality Manager, the Quality Engineer is responsible for ensuring conformance to ISO 13485 and company quality standards, as well as customer specifications. This role requires developing and implementing technical procedures related to quality control and product validation.
Key Responsibilities:
- Develop and implement technical procedures related to quality control and product validation.
- Program and operate Vision System inspection machines.
- Lead and participate in validation activities (IQ, OQ, PQ) for equipment and new and existing products.
- Support the development and manufacturing of medical products, ensuring compliance with industry regulations.
- Provide leadership and guidance on quality assurance practices during the product lifecycle.
- Analyze quality data, identify problem areas, and assist in resolving manufacturing processes or methods that affect quality.
- Perform process capability studies; recommend changes to improve quality.
- Assist the organization in enforcing the Quality System and maintain consistent standards.
- Root cause analysis and implement corrective actions.
Requirements:
- 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.
Preferred Qualifications:
- ASQ quality certification.
- Keyence, Micro Vu experience.
- Experience working in a job shop manufacturing environment.
Work Environment:
In-person manufacturing and office environment, climate controlled and mostly quiet.
