Senior Quality Engineer - Diabetes Device Process & Compliance

Planet Pharma; Tempe (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Planet Pharma in Tempe is seeking a Sr Quality Engineer to own the quality and compliance of process development and manufacturing of wafer-scale diabetes medical device products. You will partner with engineering and operations to drive Quality initiatives across Wafer & Sensor Operations and Hybrid Manufacturing.

The role emphasizes Design Controls, IQ, OQPQ, CAPA, risk assessment and change control, ensuring documentation meets regulatory requirements and supporting continuous improvement

Qualifications

• Bachelor’s degree in Engineering/Science with 4+ years of relevant experience, or Master’s with 2+ years, or PhD with 0.
• Diabetes wafer-scale medical device quality and compliance responsibilities at Tempe campus.
• Collaborates with engineering and operations to support Quality initiatives across Wafer & Sensor Operations.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocols.
• Ensures internal quality processes are compliant with governing standards.
• Collaborates with engineering and manufacturing to ensure quality standards are met.
• Implements inspection, testing and evaluation methods; conducts QA tests and statistical analysis.
• Performs CAPA investigations and change control; supports risk assessments.

Skills

Equipment Development, IQ, Process ^?

Regulatory/compliance review

Design Controls understanding

Education

Bachelor/Master/PhD in Engineering/Science or technical field

Job description

Planet Pharma in Tempe is seeking a Sr Quality Engineer to own the quality and compliance of process development and manufacturing of wafer-scale diabetes medical device products. You will partner with engineering and operations to drive Quality initiatives across Wafer & Sensor Operations and Hybrid Manufacturing.

The role emphasizes Design Controls, IQ, OQPQ, CAPA, risk assessment and change control, ensuring documentation meets regulatory requirements and supporting continuous improvement