Sr Quality Engineer - Exempt

Real Staffing; Tempe (AZ); On-site; USD 110,000 - 140,000; Full time

Job summary

Real Staffing Group in Tempe, AZ seeks a Senior Quality Engineer to support process development, manufacturing quality, and validation for wafer-scale medical devices in a diabetes-focused environment.

You will lead and participate in IQ/OQ/PQ validation, risk management, CAPA investigations, design controls, and data-driven quality improvements across development and production.

Qualifications

• Strong experience with equipment development.
• Process validation (IQ/OQ/PQ) and test method validation.
• Process characterization and design controls.
• Statistical methods (DOE, comparison testing, acceptance criteria).
• CAPA, non-conformance investigations, and change control.
• Regulatory compliance and quality systems.

Responsibilities

• Lead risk management activities including FMEA.
• Coordinate CAPA investigations and change control.
• Maintain quality metrics and data analysis.
• Collaborate with engineering and operations to ensure regulatory compliance.

Skills

Equipment development

IQ/OQ/PQ validation

Test method validation

Process characterization

Design controls

Statistical methods

Job description

Senior Quality Engineer - Job Summary

• Senior Quality Engineer supporting process development, manufacturing quality, and validation activities for wafer-scale medical devices in a diabetes-focused manufacturing environment in Tempe, AZ.
• Responsible for equipment development, process characterization, IQ/OQ/PQ validation, test method validation, design controls, and manufacturing quality compliance throughout product development and commercialization.
• Leads and supports risk management and quality systems activities, including Process FMEA, CAPA investigations, non-conformance investigations, change control, quality metrics, and continuous improvement initiatives.
• Partners cross-functionally with engineering, manufacturing, and operations teams to ensure compliance with regulatory requirements and implementation of robust, statistically sound manufacturing processes.

Key Qualifications Sought

• Strong experience with:

  • Equipment development
  • Process validation (IQ/OQ/PQ)
  • Test method validation
  • Process characterization
  • Design Controls
  • Statistical methods (DOE, comparison testing, acceptance criteria)

• Preferred experience with:

  • Medical device manufacturing
  • CAPA and non-conformance investigations
  • Process FMEA and risk assessments
  • Change control
  • Regulatory compliance and quality systems
  • Quality metrics and data analysis

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.