Senior R&D Quality Engineer, Medical Devices

Surf Search Inc.; Lake Forest (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Surf Search Inc. is seeking a Senior R&D Quality Engineer to support product development and manufacturing while ensuring compliance with FDA, ISO, and internal QMS requirements.

You will contribute as a key Quality representative on cross‑functional development teams, guiding risk management, design controls, validation, supplier quality, and regulatory compliance. The role requires leading QMS improvements, CAPA management, and collaboration with R&D, Regulatory, and suppliers to ensure

Qualifications

• Bachelor’s degree required in Mechanical, Biomedical, Metallurgical Engineering or related engineering discipline.
• 2+ years of Quality and/or Regulatory experience in the medical device industry.
• Strong knowledge of FDA Quality System requirements, cGMP, 21 CFR Part 820, ISO 13485 and other medical device standards.

Responsibilities

• Represent Quality Assurance on product design and process development teams, ensuring compliance throughout the product lifecycle.
• Develop and maintain risk management activities, including risk assessments, root cause analysis, and mitigation strategies.
• Review, develop, and approve test protocols, validation plans, reports, and other quality documentation.
• Establish and validate inspection plans, sampling methods, equipment, procedures, and statistical quality techniques.
• Maintain and improve QMS programs, including CAPA, NCR, Change Control, and Internal Audits.
• Support supplier quality activities, including supplier qualification and evaluations, incoming inspection, and resolution of quality issues.
• Design and execute testing for products, packaging, shelf-life studies, sterilization, and process validations.
• Lead and support internal and external audits while providing Quality training and guidance to engineering and inspection personnel.

Skills

Quality regulatory experience

Design controls

Risk management

Statistics

CAPA & root cause analysis

Cross-functional teamwork

Education

Bachelor’s degree in Mechanical, Biomedical, or Metallurgical Engineering

Tools

Statistical methods

Job description

Surf Search Inc. is seeking a Senior R&D Quality Engineer to support product development and manufacturing while ensuring compliance with FDA, ISO, and internal QMS requirements.

You will contribute as a key Quality representative on cross‑functional development teams, guiding risk management, design controls, validation, supplier quality, and regulatory compliance. The role requires leading QMS improvements, CAPA management, and collaboration with R&D, Regulatory, and suppliers to ensure