Staff Quality Engineer

POSITION SUMMARY:

The Staff Quality Engineer primary focus is on Design Quality to support the development and lifecycle management of surgical medical device products. This role will provide quality engineering leadership across design controls, risk management, validation, DHF documentation, while also supporting broader quality system activities such as CAPA, complaints, supplier and contract manufacturer quality, audits, and production-related quality needs. The ideal candidate is an experienced quality professional who can provide strong guidance while also supporting broader quality and production-related needs.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Participate in the review of design control activities, including design reviews, risk management, product requirements, software requirements, and usability engineering.
• Provide strong quality engineering support for the review of hardware, software, biomedical engineering (BME), and computer system validation (CSV) activities, including the review of validation strategies, protocols, reports, and associated documentation.
• Support in the review and maintenance of design history files (DHF) to ensure compliance with internal procedures and external regulations (e.g., FDA, ISO 13485).
• Review risk management activities, including Hazard Analysis, FMEA (Failure Mode and Effects Analysis), ensuring appropriate risk mitigation strategies are identified and implemented.
• Understand labeling, user requirements, instructions for use, indications for use documents and know how they are applied to the class device to be released for sale
• Provide quality engineering support for CAPA activities, including performing investigations and implementation of actions, and executing verification of effectiveness to ensure solutions are sustained and compliant with FDA/ISO and internal requirements.
• Review complaint investigations and risk analysis, including escalation to CAPA when needed.
• Complete measurement system analyses and validates test methods as needed.
• Supplier and Contract Manufacturer QA, including assessing, qualifying, auditing, drafting quality agreements, and monitoring suppliers and contract manufacturers to ensure compliance with applicable regulatory requirements, internal procedures, and product quality expectations.
• Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, Marketing) to ensure quality objectives are met.
• Participate in internal and external audits (e.g., Internal Audits, Notified Body).
• Develop and implement quality plans, procedures, and work instructions to enhance the effectiveness of the quality management system.
• Mentor other quality personnel and provide technical guidance on design quality principles and practices.
• Contribute to continuous improvement initiatives within the quality organization, identifying opportunities for process optimization.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/ExperienceRequired:

• Bachelor's degree with a minimum of 8 years of experience, or a higher degree with a minimum of 6 years of experience in Biomedical, Mechanical, Electrical, or Industrial Engineering or other equivalent science/engineering degree from an accredited university.
• 8+ years’ experience in Design Quality Engineering within the medical device with demonstrated expertise in design controls, risk management and regulatory compliance for exoscope-robotic medical devices
• Deep understanding of design control requirements (QMSR (21 CFR Part 820), ISO 13485 and risk management - ISO 14971)
• Strong analytical and problem-solving skills with the ability to investigate complex issues
• Effective written and verbal communication skills
• Ability to work both independently and collaboratively in a fast-paced environment

Desirable

• Master’s degree in Engineering
• ASQ certification (CQE, CQA)
• ISO 13485, and Medical Device Regulation (MDR)

Salary Range: $150,000 - $190,000

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