Quality Engineer

Key Responsibilities:

• Develop, implement, and maintain quality management systems in compliance with ISO 13485, FDA regulations, and other relevant standards.

• Conduct risk assessments and failure mode and effects analyses (FMEA) for new and existing products.

• Perform root cause analysis and implement corrective and preventive actions (CAPA) for quality issues.

• Review and approve design verification and validation protocols and reports.

• Support the development and execution of product testing and inspection procedures.

• Ensure proper documentation and record-keeping for all quality processes and activities.

• Conduct internal and supplier audits to ensure compliance with quality standards.

• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure product quality and compliance.

• Provide quality engineering support during new product development and introduction.

• Participate in continuous improvement initiatives to enhance product quality and process efficiency.

Qualifications:

• Bachelor's degree in engineering, biomedical engineering, or a related field.

• Minimum of 3-5 years of experience in quality engineering within the medical device industry.

• Strong knowledge of ISO 13485, FDA QSR, and other relevant regulations and standards.

• Experience with risk management processes, including FMEA and CAPA.

• Proficient in quality management systems and tools.

• Excellent problem-solving, analytical, and communication skills.

• Ability to work effectively in a team environment and manage multiple projects simultaneously.

• Certified Quality Engineer (CQE) or equivalent certification is a plus.