Quality Engineer

Summary

The Sr. Quality Engineer will play a key role in ensuring the reliability, safety, and compliance of electromechanical medical devices throughout the product lifecycle. This individual will support design controls, risk management, verification/validation activities, supplier quality, and continuous improvement initiatives. The ideal candidate brings deep experience with electromechanical systems, FDA and ISO 13485 compliance requirements, and hands‑on proficiency with the Greenlight Guru eQMS platform.

• Lead quality engineering activities for electromechanical medical devices, including design reviews, requirements traceability, verification/validation, and risk management.
• Maintain and optimize quality processes within Greenlight Guru, including document control, CAPA, nonconformance management, complaint handling, and change control.
• Support design control documentation, ensuring complete and compliant DHF/DMR records.
• Partner with R&D and manufacturing teams to identify root causes, implement corrective actions, and drive continuous improvement.
• Conduct and support internal audits, supplier audits, and inspection readiness activities.
• Develop inspection methods, test procedures, and acceptance criteria for electromechanical components and assemblies.
• Collaborate with suppliers to ensure component quality, resolve issues, and maintain incoming inspection standards.
• Analyze quality data trends, produce reports, and present findings to cross‑functional teams.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and other applicable regulatory requirements.

• Bachelor's degree in Mechanical, Electrical, Biomedical, or related engineering discipline.
• Minimum of 5 years of Quality Engineering experience in a regulated medical device environment.
• Strong background in electromechanical systems, including sensors, motors, actuators, PCBAs, and integrated assemblies.
• Hands‑on experience with Greenlight Guru eQMS, including document control and quality process modules.
• Solid understanding of FDA QSR, ISO 13485, ISO 14971, and design control requirements.
• Experience with risk management tools (FMEA, pFMEA, dFMEA), root cause analysis, and statistical analysis.
• Demonstrated ability to lead cross‑functional problem solving and drive quality improvements.
• Excellent communication, documentation, and organizational skills.
• ASQ CQE certification is a plus but not required.

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.

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