Quality Assurance Operations Engineer

The Quality Operations Engineer role requires a blend of technical expertise, analytical skills, and effective communication to ensure that our products meet the highest standards.

Main Responsibilities:

• Develop, implement, and maintain quality assurance policies, procedures, and standards to ensure compliance with regulatory requirements (e.g., 21 CFR 820, ISO 13485).
• Oversee the execution of quality assurance activities across the product lifecycle, from development through post-market surveillance.
• Ensure that all quality processes comply with relevant medical device regulations and standards.
• Identify, document, and track product defects and non-conformities. Investigate root causes and implement corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams to resolve quality issues and ensure timely resolution.
• Develop and implement inspection and testing procedures to ensure products meet established quality standards.
• Conduct audits and inspections to assess adherence to quality standards and regulatory requirements.
• Analyze quality metrics and data to identify areas for improvement and implement best practices.
• Conduct verification and validation activities, including hardware and software testing, and document test results.
• Drive continuous improvement initiatives within the quality management system and overall product quality.
• Prepare and present detailed quality reports, including audit findings, test results, and performance metrics.
• Provide training and support to team members and stakeholders on quality standards, procedures, and best practices.
• Act as a quality advocate within the organization, promoting a culture of quality and compliance.

Qualifications & Requirements

• Must Have
  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Assurance, or a related field.
  • Proven experience of minimum 3 years  as a Quality Assurance Engineer in the medical device industry.
  • Experience with quality management systems (QMS) and tools such as risk management (ISO 14971), CAPA, and non-conformance management.
  • Strong analytical and problem-solving skills, with a keen attention to detail.
  • Excellent communication skills, both written and verbal, with the ability to interact effectively with regulatory bodies, team members, and other stakeholders.
  • High level English skills – writing, reading and speaking.
• Nice to Have
  • Proficiency in design control processes, including design verification and validation.
  • Knowledge of statistical analysis and quality improvement methodologies (e.g., Six Sigma, Lean).
  • Familiarity with electronic quality management systems (eQMS) and documentation tools.
• Travel
  • Willing to travel as required, 20% traveling.
• Physiological
  • Color blindness test.