Job Description

Join an innovative and fast-paced organization at the forefront of biotech and medical device development. We are seeking a highly skilled Quality Engineer III to lead and support critical elements of our Quality Management System (QMS), with a strong focus on supplier quality, regulatory compliance, and continuous improvement.

Position Summary

The Quality Engineer III plays a key role in managing Quality System activities, including non-conformance management (NCMRs), corrective and preventive actions (CAPAs), batch record (DHR) review, product release, engineering change orders, and supplier oversight. This is a hands-on position ideal for someone who thrives in a regulated manufacturing environment and has a passion for driving product and process excellence.

Key Responsibilities

• Develop and implement quality assurance protocols for components, assemblies, and finished products.
• Lead root cause investigations and drive effective corrective actions.
• Perform GD&T evaluations and tolerance stack-up analysis.
• Manage supplier qualification processes, including audits, validations, and performance monitoring.
• Collaborate with suppliers on non-conformance issues and implement supplier corrective action requests (SCARs).
• Review engineering drawings, specifications, and protocols to ensure regulatory and quality compliance.
• Participate in internal review boards (MRBs), batch record reviews, and product release processes.
• Analyze and report on quality metrics, audit results, and continuous improvement initiatives.
• Provide quality support to cross-functional teams including Manufacturing, Engineering, and Regulatory Affairs.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Quality Management, or a related field
• At least 8 years of experience in a quality role within medical device manufacturing.
• Minimum 5 years of experience working with software-driven electronic medical devices.
• Minimum 2 years of experience conducting supplier audits and managing supplier qualifications.
• Strong working knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO 9001, and other applicable standards.

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