What are the responsibilities and job description for the Quality Assurance Engineer position at Kelly Science, Engineering, Technology & Telecom?
Job Description
The Supplier Quality Engineer plays a crucial role in supporting the quality and regulatory aspects of purchased components and supplier relationships for medical bed devices at the Batesville Manufacturing site.
This position is responsible for overseeing and/or assisting with various Quality Engineering functions, ensuring compliance with QSR regulations, policies, and procedures.
- Serve as the 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 suppliers' engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements.
Responsibilities
- Serve as the 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 suppliers' 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 assigned areas.
- Ensure appropriate controls 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.
