Supplier Quality Engineer
On-sitePortsmouth, New Hampshire, United States
Job Summary
Manage product quality by implementing supplier/contract manufacturer evaluation procedures, using risk management tools, and auditing current and prospective vendors. Identify and mitigate supplier risks while participating in the supplier selection and monitoring process. Audit suppliers to ensure compliance with quality system requirements and material specifications, then issue technical direction to supplier corrective action requests. Monitor and compile reports for Supplier KPIs and scorecards, while assisting with internal auditing, complaint handling, and CAPA fulfillment. Provide engineering support for product design and development projects as needed. Requires a Bachelor's degree in engineering with five years of quality assurance experience and knowledge of ISO 13485 and 21CFR compliant systems.
Required Qualifications
- Bachelors' degree in an engineering or related scientific field
- minimum of 5 years of experience in quality assurance
- Knowledge of ISO 13485 and 21CFR compliant quality systems
- Experience with internal and external auditing
- Experience applying statistical methods to quality assurance
- Ability to read and understand the current version of the Training Matrix Q620-FRM-03 or equivalent
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.