Senior Quality Engineer

Role Overview

The Senior Quality Engineer ensures day-to-day compliance with applicable quality and regulatory standards, providing leadership to the Quality Engineering Support personnel within the site.

What You Will Do

Responsible for In Process Quality Controls, day-to-day quality performance in manufacturing, and continuous improvement with systemic approaches. Manage complaint/NCR database and address Customer issued SCARs.

Why It Might Be a Fit

Requires a minimum of 5 years' experience in a manufacturing environment as a quality engineer or equivalent, with demonstrated working knowledge of ISO 9001 and 13485 standards.

Requirements

• Minimum of 5 years' experience in a manufacturing environment as a quality engineer or equivalent
• Demonstrated working knowledge of ISO 9001 and 13485 standards
• Work experience in a cGMP FDA 21 CFR Part 820, AS9100, AS9102 and ISO 14001 environment is strongly desirable
• A Degree in Engineering or related technical discipline, and/or a combination of education and experience is required
• ASQ CMQ/OE, CQE or CQA certification highly desirable

Benefits

• Equal opportunity/affirmative action employer
• Accommodations for applicants with disabilities