What are the responsibilities and job description for the Supplier Quality Engineer position at Kelly Science, Engineering, Technology & Telecom?
Job Description:
Supplier Quality Engineer
This position is responsible for supporting quality and regulatory matters related to purchased components and supplier relations associated with medical bed devices at the Batesville Manufacturing site.
Key Responsibilities:
- Serve as primary point of contact for quality-related matters associated with medical bed devices.
- Drive quality system improvements and ensure compliance to regulatory and procedural requirements.
- Interface with suppliers' engineering and quality organizations to address reported problems impacting functionality, quality, and regulatory requirements.
- Work with design engineering to determine receiving inspection requirements of purchased components and finished product.
- 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 Health Hazard Evaluation activities for assigned areas.
- Evaluate controls (key metrics) defined, implemented, and completed for all appropriate operations.
- Process Quality Records accurately and timely, adhering to 21CFR820 regulations.
- Collect, analyze, and track key data for Batesville manufacturing site suppliers, monitoring entity quality and key performance indicators.
- Provide training on proper implementation and use of quality tools and procedures as required.
Requirements:
- Must be currently employed in the United States with active employment authorization documents.
- No visa sponsorship available now or in the near future for this position.
Benefits:
- Competitive pay
- Paid holidays
- Year-end bonus program
- Recognition and incentive programs
- Access to continuing education via Kelly Learning Center
