POSITION SUMMARY:

The Quality Engineer will support the Cretex Medical New Product Development (NPD) team, providing quality assurance expertise within a medical device environment. This role is responsible for defining, implementing, and improving quality-related practices, ensuring compliance with industry standards and regulatory requirements. The position will also provide technical guidance, support measurement methodologies, and contribute to the successful launch of new products.

Responsibilities:

• Quality engineering support for NPD engineer team
• Develop inspection requirements; facilitate inspection method development and validations; resolve discrepant material issues and create and maintain quality document such as control plans and inspection plans
• Support development activity of processes, equipment, and metrology
• Analysis of process data and create reports
• Support and comply with the company Quality System, ISO, and medical device requirements

Qualifications:

• Bachelor’s degree in Mechanical, Industrial, or another Engineering discipline.
• 1+ years of engineering experience in a machining or manufacturing environment.
• Strong knowledge of quality systems, regulatory requirements, and industry standards.
• Advanced proficiency in blueprint reading and Geometric Dimensioning and Tolerancing (GD&T).
• Proven expertise in metrology, including the development of inspection methods.
• Advanced statistical knowledge, including Design of Experiments (DOE) and capability studies to support process validation.
• Proficiency with statistical analysis software, particularly Minitab.

• Quality engineering support for NPD engineer team
• Develop inspection requirements; facilitate inspection method development and validations; resolve discrepant material issues and create and maintain quality document such as control plans and inspection plans
• Support development activity of processes, equipment, and metrology
• Analysis of process data and create reports
• Support and comply with the company Quality System, ISO, and medical device requirement