Quality Engineer - Elevate Med Devices & Pharma

ATR International; Menlo Park (CA); On-site; USD 115,000 - 145,000; Full time

Job summary

ATR International is seeking an Operations Quality Engineer to support Class II/III pharmaceutical and medical device production. You will drive quality systems, manage NCMR and CAPA, and collaborate with cross-functional teams to maintain robust work instructions and risk controls.

You will lead R&R, TMV, IQ/OQ/PQ validation activities, perform root cause analyses (5-Why, Fishbone), and provide floor support to operators, inspectors, and technicians to sustain compliant, high-quality

Qualifications

• Bachelor’s degree in Engineering or related field.
• 2+ years of quality engineering in pharma, medical device, or related manufacturing.
• Hands-on experience with NCMRs, CAPAs and risk management protocols.
• Proficiency with Gage R&R, TMV and IQ/OQ/PQ validation processes.
• Strong problem-solving using Six Sigma, 5-Why and Fishbone methods.

Responsibilities

• Quality Standards & Protocols: Develop, modify, apply and maintain quality standards for materials into finished products.
• Inspection & Testing: Design procedures for inspecting and testing product quality and machine accuracy.
• CAPA/NCMR: Lead and support non-conforming material reports and corrective actions.
• Process & Equipment Validation: Plan and execute Gage R&R, TMV and IQ/OQ/PQ validations.
• Root Cause Analysis: Apply structured problem solving to investigate quality issues.
• Daily Operations Support: Provide technical guidance to operators, inspectors and technicians.
• Continuous Improvement: Recommend enhancements to systems and processes to improve quality.

Skills

NCMR / CAPA management

Risk management

Six Sigma

Root cause analysis

Statistical analysis

Quality systems

Education

Bachelor’s degree in Engineering

Tools

Gage R&R

Test Method Validation

IQ/OQ/PQ

Job description

ATR International is seeking an Operations Quality Engineer to support Class II/III pharmaceutical and medical device production. You will drive quality systems, manage NCMR and CAPA, and collaborate with cross-functional teams to maintain robust work instructions and risk controls.

You will lead R&R, TMV, IQ/OQ/PQ validation activities, perform root cause analyses (5-Why, Fishbone), and provide floor support to operators, inspectors, and technicians to sustain compliant, high-quality