Job Title: Supplier Quality Engineer
$35.00 - $40.00/hour
Position Summary: The Supplier Quality Engineer performs activities to develop, maintain and improve the supplier quality system and reduce quality issues related to supplier quality. Additionally, the position will work with suppliers to meet company's expectations for quality and reliability through supplier evaluations, visits and formal quality audits. The position will use quality processes required for Medical Device manufacturers and initial distributors including compliance with FDA, GMP, ISO, Canadian Medical Device Regulations and similar regulatory quality requirements.
Essential Duties and Responsibilities:
- Lead overall quality improvement of Supplier Quality system activities, processes and integrating systems, leading to tangible improvements for the organization.
- Perform required evaluations, visits and auditing of suppliers to FDA, ISO and customer required standards.
- Lead supplier development activities to evaluate current and potential suppliers for their ability to meet customer and regulation expectations.
- Initiate, review and audit Supplier Corrective Action Reports.
- Work with suppliers for immediate problem resolution and containment to minimize impact on business activity.
- Work closely with supply chain, purchasing and warehousing groups to drive continuous improvement activities pertaining to supplier quality initiatives.
- Develop and monitor improvements in Supplier Quality matrices.
- Supports the company’s deployment of Quality System processes and procedures and promotes ongoing education of the company’s knowledge of the Quality System and regulatory requirements.
- Assist with internal quality audits, as necessary.
- Bachelor’s degree or 10 years required experience in diagnostics or medical device environment or equivalent experience in the Armed Forces. Bachelor’s degree with a specialization in science, engineering or health services preferred.
- 5-7 years total quality assurance experience in a diagnostics or medical device environment.
- Experienced with cGMP, 21CFR820, ISO (9001, 13485), and Canadian Medical Device Regulations.
- ASQ CQA or CQE a plus.
- Microsoft Word, Outlook, Excel, PowerPoint, Access.
- Potential travel down the road of 15% - 25%.