What are the responsibilities and job description for the Supplier Quality Engineer position at Katalyst CRO?
Roles & Responsibilities
- Serve as a primary point of contact for quality related matters associated with support for medical bed devices.
- Drive quality system improvements and ensure compliance to regulatory and procedural requirements.
- Interface with supplier's engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements.
- Work with design engineering to determine receiving inspection requirements of purchased components and finished product. Provide technical quality engineering support to receiving inspection.
- Support operations in trouble-shooting non-conformities to confirm part defects.
- Participate in external and internal regulatory compliance inspections.
- Assist in development, review and approval of Supplier process and equipment validation/qualifications (IQ, OQ, & PQ).
- Participate in Corrective Action System activities including evaluation of failure investigation and corrective action plans, root cause analysis and follow-up activities.
- Lead the Health Hazard Evaluation activities for the assigned areas.
- Ensure appropriate controls (key metrics) are defined, implemented, and satisfactorily completed for all appropriate operations.
- Ensure accurate and timely processing of all Quality Records along with the company's regulatory compliance profile per 21CFR820 regulations.
- Collect, analyze, and track key data for Batesville manufacturing site suppliers related to entity quality and to monitor and to monitor key performance indicators by interfacing with key partners across the corporation.
- Provide training to ensure proper implementation and use of quality tools and procedures as required.
