What are the responsibilities and job description for the Quality Engineer position at Katalyst CRO?
Responsibilities
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the lifecycle on newly qualified parts and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
- Collaborates with Component Engineers to develop and deliver the Product.
- Acceptance Sampling Strategy and Control Plans for new components.
- Bachelor's degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
- Product Part Approval Process Experience.
- Understanding of IQ, OQ, PQ.
- Molding Experience.
- Understanding of GD&T.
- Degree in Engineering or Scientific discipline.
- CAD Experience.
- Detail-oriented with strong commitment to quality and to the workplace.
- Excellent analytical, organizational, and communication skills. Strong ability to work with multidisciplinary and global teams.
- High tolerance for change, and ability to multi-task continuously.
- Strong negotiation, conflict management, and influence management skills.
- Experience in the medical device industry.
- Sponsorship/ Corp to Corp is not available for this position.
