Act as the Quality core team member for sustaining engineering projects.
Participate in design control activities, including design reviews, risk management, and verification and validation planning and execution.
Support the development and maintenance of design and development files (DDFs) to ensure compliance with internal procedures and external regulations (e.g., FDA, ISO 13485).
Perform and/or review risk management activities, including Hazard Analysis, FMEA (Failure Mode and Effects Analysis), and risk-benefit analysis, ensuring appropriate risk mitigation strategies are identified and implemented.
Provide quality engineering support for CAPA activities, including performing investigations and implementation of actions, and executing verification of effectiveness (VOE) to ensure solutions are sustained and compliant with FDA/ISO and internal requirements.
Author field issue assessments using post-market data, complaint investigations, and risk analyses in compliance with 21 CFR 806 and EU MDR.
Participate in internal and external audits (e.g., FDA, Notified Body).
Mentor junior quality engineers and provide technical guidance on design quality principles and practices.
Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, Marketing) to ensure quality objectives are met.
Develop and implement quality plans, procedures, and work instructions to enhance the effectiveness of the quality management system.
Contribute to continuous improvement initiatives within the quality organization, identifying opportunities for process optimization.
Job Qualifications:
Minimum Requirements
Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, or related field)
5–7 years of experience in Design Quality Engineering within the medical device industry
Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485
Hands-on experience with design controls and risk management (ISO 14971)
Basic understanding of corrections/removals processes (21 CFR Part 806)
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
Preferred Qualifications
Master’s degree in Engineering
Experience with statistical software (e.g., Minitab, JMP)
