Senior Quality Engineer - Medical Devices & Wafer-Scale

Lancesoft; Tempe (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Lancesoft in Tempe, AZ is seeking a Quality Engineer focused on development and manufacturing of wafer-scale diabetes medical device products. You will work with engineering and operations to support Quality initiatives and ensure compliance with applicable regulatory requirements.

Candidate should have a strong background in IQ, process characterization, OQPQ, validation, and the ability to review documentation for compliance across internal procedures and regulatory standards.

Qualifications

• Must have strong statistical analysis techniques and DOE design and execution.
• Experience with general quality principles, procedures, and methodologies.
• Proficiency in Microsoft Office Applications (Word, Excel, PowerPoint, Teams).
• Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
• Strong communication skills, both technical writing and presentation, with experience in presentations.

Responsibilities

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into finished products.
• Ensure internal quality processes, procedures, and systems comply with governing standards.
• Collaborate with engineering and manufacturing to meet quality standards.
• Design or specify inspection/testing mechanisms; conduct quality assurance tests; perform statistical analysis to assess cost and responsibility for nonconforming products.
• Support and drive CAPA investigations and effectiveness verification testing.
• Lead and/or support investigations of non-conforming product and coordinate cross-functional teams.

Job description

Lancesoft in Tempe, AZ is seeking a Quality Engineer focused on development and manufacturing of wafer-scale diabetes medical device products. You will work with engineering and operations to support Quality initiatives and ensure compliance with applicable regulatory requirements.

Candidate should have a strong background in IQ, process characterization, OQPQ, validation, and the ability to review documentation for compliance across internal procedures and regulatory standards.