Sr. R&D Quality Engineer

Our medical device client is searching for a Senior R&D Quality Engineer will support product development and manufacturing activities while ensuring compliance with FDA, ISO, and internal Quality Management System requirements. This individual will serve as a key Quality representative on cross-functional development teams, providing guidance on risk management, design controls, validation, supplier quality, and regulatory compliance.

The role will also support continuous improvement of the site QMS and partner closely with R&D, Manufacturing, Regulatory, suppliers, and other stakeholders to ensure products and processes consistently meet quality and regulatory standards.

• Bachelor’s degree in Mechanical, Biomedical, Metallurgical Engineering, or a related engineering discipline.
• 2+ years of Quality and/or Regulatory experience within the medical device industry.
• Strong knowledge of FDA Quality System requirements, cGMP, 21 CFR Part 820, ISO 13485, and medical device regulatory standards.
• Experience with design controls, Quality Management Systems, risk management, and product development processes.
• Demonstrated experience managing deviations, investigations, root cause analysis, CAPA, and risk analysis.
• Strong statistical background with experience applying statistical methods to quality and manufacturing processes.
• Quality or Regulatory certification such as CQE, CQA, CMQ/OE, or RAC preferred

• 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, 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.

Occupational Code 17-2199 – Engineers, All Other