Katalyst Healthcares and Life Sciences
Location: all cities,PA, USA
Date: 2024-11-22T19:25:41Z
Job Description:
Responsibilities:
- Manage supplier quality activities, develop, and establish supplier related quality processes, monitor process performance and monitor/report on supplier KPI's.
- Lead supplier quality engineering activities for the site, across all commodities.
- Oversee and lead supplier quality assurance activities for the US site including processes that support First Article Inspection, Supplier monitoring & prioritization, auditing, Supplier corrective action and Supplier quality improvement. Assume direct responsibility for some of the key suppliers for the site and support tasks using the processes above.
- Manage tasks and performance of employees; set and track objectives, assess performance on a regular basis, provide motivation and create effective development and training plans.
- Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for high leverage/critical sustaining parts and new products sourced to suppliers and contract manufacturers.
- Measure and communicate supplier performance on key metrics and the corresponding continuous improvement plans.
- Perform and coordinate supplier surveys, quality system and process control audits to applicable ISO standards.
- Support internal and external audits as they relate to Purchasing/SQA processes.
- Participate as an active member in the New Product development process, supplier evaluation team and the sourcing core extended team. Ensure quality and regulatory requirements are implemented at key suppliers through FAI process, auditing and contracting (QAA).
- Monitor and drive supplier corrective action process and continuous improvement activities that directly impact supplier performance.
- Willingness and flexibility for business travel both domestically and abroad, when required.
- Performs other duties as needed and assigned.
Requirements:
- BS engineering or another related technical field.
- 8 to 10 years in manufacturing/engineering/quality engineering experience with a minimum of 5 years in a leadership role for supplier quality
- Working knowledge of medical device manufacturing strongly preferred.
- Knowledge of ISO 13485 and FDA regulations.
- Experience with statistical methods preferred.
- Experience with direct supervision of employees required.