SUMMARY: Maintain the quality system and support supplier and incoming quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices. This is a hybrid role. The incumbent will be required to be on site as well as work from home.

The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

Work with suppliers and the Purchasing department to address quality issues with raw materials and components.

Maintain supplier approvals and certifications.

Review supplier quality agreements.

Make use of statistical techniques,risk analysis, Gage R&R, Cpk, ANOVA and DOE

Solve problems using Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D.

Maintain Quality Records.

Perform Corrective Actions and Non-conformance assessments.

Perform supplier audits as well as internal audits.

Support Incoming Inspection.

Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends.

Participate in and lead continual improvement projects.

Travel up to 25% required for supplier support and audits.

NON-ESSENTIAL FUNCTIONS: In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

Qualifications:

·Bachelor’s Degree in Industrial, Mechanical or Biomedical engineering or equivalent experience. ·

Very good written and verbal communication skills. ·

At least 5 years of experience working with suppliers; preferably in the medical device or other regulated industry. ·

CQA or certified biomedical auditor certification helpful but not required. ·

Experience with supplier audits and supplier management. ·

Experience with quality management systems standards (ISO13845, ISO9001, AS9100) ·

Accuracy, thoroughness, attention to detail, legibility in completing records is essential. ·

Lean and 6Sigma knowledge a plus.