Principal Supplier Quality Engineer
Plymouth, MN Posted: 2/20/2019
PRINCIPAL SUPPLIER QUALITY ENGINEER
This Principal Supplier Quality Engineer is responsible for leading and improving the supplier quality program. This role will lead and drive supplier evaluation, supplier performance monitoring, and supplier feedback and change control. Additionally, the Supplier Quality Engineer will assist with supplier selection, material qualification, procurement and delivery.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Ensure that all required annual supplier’s surveys are completed, feedback obtained, and action plans and reports are created as necessary for each supplier.
- Ensure that all supplier files are annually updated and maintained
- Responsible for the oversight of the Corporate ASL. This includes all system updates/processes for new suppliers and changes to existing suppliers.
- Create and maintain seamless on-boarding and verification activities for suppliers as it relates to Supplier Quality.
- Responsible for creating and developing the annual supplier audit plan/schedule
- Responsible for ensuring that all supplier evaluation reports are completed as required
- Develop the necessary tools for suppliers to communicate changes to the company and ensure that the necessary evaluation and approval has taken place.
- Responsible for developing and maintaining a Supplier Quality Scorecard – thus developing meaningful metrics that suppliers can use to improve delivery and quality to the company and also their internal processes. Responsible for initiating the necessary NCR/SCAR to suppliers based on performance.
- Lead and establish a cross-functional supplier management meeting in order to review and discuss supplier performance and status and taking necessary actions as required.
- Establish, develop, and improve relationships with suppliers. Lead improvement efforts and utilize training methodologies in focused areas such as inspection techniques, verification activities, NCR, CAPA, FMEA, Control Plans, Capability Studies, problem solving techniques, etc.
- Ability to work cross-functionally with all levels of the organization
- B.S. in Engineering or a technical degree with a proven track record in a medical device and/or combination device environment.
- Lead Auditor Certification
- Minimum 7 years medical device and/or combination device experience with at least 5 years in a Supplier Quality/Development role.
- Working knowledge of ISO13485, 21 CFR Part 820 and Parts 210 & 211 Quality Systems.
- Strong analysis and problem-solving skills including SPC, DOE and statistics. Six Sigma Black Belt preferred.
- Ability to act as the public face with suppliers
- Ability to travel up to 30%
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