Quality Engineer

We are seeking a Quality Engineer to join our team and ensure compliance with medical device regulations and industry standards. The ideal candidate will have 1-3 years of experience in quality engineering within the medical device sector and be well-versed in quality management systems, regulatory requirements, and continuous improvement initiatives.Key Responsibilities:Support the implementation and maintenance of Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other applicable regulations.Conduct root cause analysis and corrective/preventive actions (CAPA) to resolve quality issues.Participate in internal and external audits, ensuring compliance with regulatory and company requirements.Assist in the development and review of design verification and validation (V&V) protocols for new and existing medical devices.Support risk management activities, including FMEA (Failure Modes and Effects Analysis) and risk assessments.Work with cross-functional teams to support supplier quality management, including audits and corrective actions.Review and approve engineering change orders (ECOs), deviations, and non-conformance reports.Ensure process validation (IQ, OQ, PQ) is conducted per regulatory and company standards.Maintain and improve documentation control processes within the QMS.Support continuous improvement initiatives to enhance product quality and manufacturing processes.Qualifications & Requirements:Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related field.1-3 years of experience in a quality engineering role within the medical device industry.Strong understanding of ISO 13485, FDA 21 CFR Part 820, MDR, and other global medical device regulations.Experience with CAPA, Root Cause Analysis, and Risk Management (FMEA, HACCP, etc.).Knowledge of design control, process validation (IQ/OQ/PQ), and statistical analysis tools (Minitab, JMP, etc.) is preferred.Familiarity with supplier quality processes and regulatory audits.Excellent analytical, problem-solving, and communication skills.Strong attention to detail and ability to manage multiple tasks effectively.Certifications such as CQE (Certified Quality Engineer) or Six Sigma Green Belt are a plus.

Created: 2025-02-04