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.