Job Description

Quality Engineer Sr Position Summary

The Quality Engineer Sr will support the New Product Introduction (NPI) team enabling business growth by providing quality assurance expertise within a regulated medical device contract manufacturing environment. This role is accountable for defining, implementing, and improving quality-related practices, ensuring compliance with industry standards and regulatory requirements. The Quality Engineer will be responsible for providing quality assurance support for manufacturing. This position is responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.

Responsibilities

• Provide Quality Engineering support to NPI project management in a customer-facing capacity
• Perform the statistical analysis of data to assess process capability (Cpk/Ppk), first article acceptance (FAI), and visual inspection
• Create validation reports to summarize the results validation runs and uses data in a manner that compels corrective action where needed
• Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection plans
• Act as the quality interface for a NPI team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis
• Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions
• Coach and mentor Quality Engineer levels, I, II, and III
• Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge)
• Lead and participate in large company-wide projects providing quality recommendations

Preferred Qualifications

• Bachelor’s Degree in Mechanical, Industrial, or in another Engineering or Physical Science
• Knowledge of quality systems, regulatory requirements, and industry standards
• Ability to consistently achieve short and long-term business results
• Demonstrate leadership Skills
• Experience with ERP and quality systems