What are the responsibilities and job description for the ISO 13485 Compliance Officer position at Custom Wire Technologies?
Quality Assurance Position
We are seeking a skilled Quality Engineer to join our team at Custom Wire Technologies. As a Quality Engineer, you will be responsible for ensuring the quality of our medical components and collaborating with cross-functional teams to develop and implement quality control procedures.
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.
Responsibilities:
- Develop and implement quality control procedures to ensure compliance with ISO 13485 and company quality standards.
- Collaborate with cross-functional teams to develop and implement quality control procedures.
- Conduct process capability studies and recommend changes to improve quality.
- Lead and participate in validation activities (IQ, OQ, PQ) for equipment and new and existing products.
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.
Benefits:
- Comprehensive benefits package including medical, dental, vision, life and disability insurance.
- Paid Time Off and 401(k) with company match.
- Profit Sharing and Paid Holidays.
