Quality Assurance Engineer (ISO 13485)

• Conducts engineering activities in compliance with FDA Regulations, ISO 13485, and other national and international quality and regulatory requirements and standards.
• Leads product quality assurance and quality engineering activities to drive strong engineering and technical knowledge.
• Creates quality assurance, engineering programs, and initiatives to ensure products are developed and manufactured according to applicable requirements.
• Collaborates on investigations of NCR’s and complaints as necessary; suggests corrective and preventive actions based on engineering analysis and review; suggests effective solutions to drive continuous and measurable improvements.
• Works with various departments to ensure highest quality products and processes are developed, deployed, and meet all engineering requirements; activities include but not limited to product design testing, process testing, characterization, qualification, validation, and risk analysis/FMEA.
• Collaborates to create systems for the identification, analysis, correction, and prevention of quality issues; identifies areas for improvement as needed.
• Participates in quality engineering projects from inception to deployment.
• Participates in CAPA Management and other quality engineering projects.
• Participates in trainings for quality engineering tools within the organization using ISO 14971.
• Collaborates with team members to provide technicians and R&D personnel to provide technical leadership in problem resolution, process streamlining, and continuous improvement activities.
• Analyzes data and trends; reports results to management.
• Collaborates with team members to complete failure investigations and root cause analysis.
• Collaborates in design verification testing for design control projects.
• Performs returned product analysis and failure investigation activities.
• Ensures procedures and regulations are adequately followed during NCMR process.
• Ensures calibration and preventive management systems meet compliance requirements.
• Identifies the optimization of complex manufacturing processes using engineering methods for manufacturing design and continuous process improvement.
• Identifies opportunities for re-design and/or design of more complex equipment, tools, and fixtures to improve manufacturing processes and reduce risk.
• Performs other related duties and projects as business needs require at direction of management

Minimum Qualifications:

• Bachelor’s degree in Science, Engineering, or related field; or equivalent combination of experience and training; advanced degree preferred
• Minimum three (3) years of experience in quality engineering and risk management.
• Knowledge of FDA regulations, ISO 13485, and other applicable international quality standards.
• Knowledge of risk management (ISO 14971), design controls, and validation methodologies.
• Proven analytical, problem-solving, and communication skills.
• Proficiency in quality and statistical analysis tools such as Minitab or equivalent software.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification, preferred.
• Experience with combination products or Class I/II medical devices, preferred.
• Familiarity with EU MDR and UDI regulatory requirements, preferred.