What are the responsibilities and job description for the Supplier Quality / Manufacturing Engineer position at Katalyst CRO?
Job Description
The Supplier Quality Engineer is responsible for supporting the quality and regulatory related matters for purchased components and supplier relations associated with the medical bed devices at the Hillrom Batesville Manufacturing site. This position will also be responsible overseeing and/or assisting with a variety of Quality Engineering functions and ensuring compliance with QSR regulations and Hill-Rom policies and procedures. In addition, this position will work to provide the necessary data to make effective quality and business decisions, and implement sound, data-driven quality and business solutions that emphasize quality system compliance. The Supplier Quality Engineer will need to maintain a teamwork approach to all tasks and nurture professional relationships with other departments and outside agencies.
Responsibilities: .
The Supplier Quality Engineer is responsible for supporting the quality and regulatory related matters for purchased components and supplier relations associated with the medical bed devices at the Hillrom Batesville Manufacturing site. This position will also be responsible overseeing and/or assisting with a variety of Quality Engineering functions and ensuring compliance with QSR regulations and Hill-Rom policies and procedures. In addition, this position will work to provide the necessary data to make effective quality and business decisions, and implement sound, data-driven quality and business solutions that emphasize quality system compliance. The Supplier Quality Engineer will need to maintain a teamwork approach to all tasks and nurture professional relationships with other departments and outside agencies.
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.
