Quality Engineer

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

The Operations Quality Engineer plays a vital role in supporting the production of Class III pharmaceutical and medical device products. Working closely with cross-functional teams, this role resolves technical issues through NCMR and CAPA processes, drives continuous process improvements, and maintains work instructions. On a daily basis, you will support operators, inspectors, and technicians in manufacturing and inspecting components, sub-assemblies, and finished goods.

Key Responsibilities

• Quality Standards & Protocols: Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products. Collaborate with engineering and manufacturing teams to ensure robust quality standards are in place.
• Inspection & Testing: Devise and implement methods and procedures for inspecting, testing, and evaluating product precision and equipment accuracy. Design or specify inspection mechanisms and perform statistical analysis to evaluate non-conforming materials.
• Corrective & Preventive Action (CAPA): Lead and support Non-Conforming Material Reports (NCMR) and CAPA processes. Ensure corrective measures meet reliability standards and documentation remains strictly compliant.
• Process & Equipment Validation: Plan and execute Gage R&R, Test Method Validations (TMV), and Equipment Validations (IQ/OQ/PQ).
• Root Cause Analysis: Apply structured problem-solving methodologies (5-Whys, Fishbone diagrams, Cause and Effect analysis) to investigate quality issues and implement permanent fixes.
• Daily Operations Support: Provide technical guidance and floor support to operators, inspectors, and technicians on production procedures and quality standards.
• Continuous Improvement: Recommend enhancements to systems and processes to optimize operational effectiveness and maintain risk management standards.

Qualifications & Experience

Required:

• Education: Bachelor’s degree in an Engineering field.
• Experience: Minimum of 2 years of quality engineering experience in a Class II or Class III medical device or combination/pharma manufacturing environment (or Advanced Degree with 0 years of experience).
• Technical Expertise: Hands-on experience managing NCMRs, CAPAs, and risk management protocols.
• Validation Skills: Demonstrated proficiency with Gage R&R, Test Method Validation (TMV), and IQ/OQ/PQ processes.
• Problem-Solving: Proven ability to apply Six Sigma, 5-Why, Fishbone, and other root-cause analysis tools.