QA/QC Executive

Key roles and responsibilities:

• Implement and monitor quality management systems in accordance with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements.
• Establish supplier quality controls and conduct routine assessments/audits of vendors.
• Collaborate with vendors and production teams to strengthen incoming material and product quality through root cause analysis and corrective action implementation.
• Oversee product distribution processes to ensure alignment with quality standards and applicable regulatory requirements.
• Plan, schedule, and execute internal/external audits efficiently within defined timelines.
• Prepare, issue, and obtain approval for audit reports promptly.
• Support audit practice by identifying training needs and developing relevant training modules for team members.
• Maintain personal training on current compliance regulations and standards.
• Conduct regular training sessions for employees on Quality System standards (ISO 13485, ISO 14971, 21 CFR 820).
• Champion Lean, Six Sigma, and Kaizen initiatives to enhance process capability and eliminate non-value-adding activities.
• Develop, review, and refine Standard Operating Procedures (SOPs), internal audit frameworks, and risk assessment models.
• Monitor, analyze, and report on key quality metrics, non-conformances, and continuous improvement initiatives.
• Lead and manage the Corrective and Preventive Action (CAPA) process from initiation through closure.
• Coordinate root cause investigations and ensure effective, sustainable corrective actions.
• Oversee verification and validation activities to ensure compliance with ISO 13485 regulatory standards.
• Review marketing materials, website content, and social media claims to ensure statements and intended use align with approved regulatory and quality requirements.
• Develop and implement strategies that align and integrate the Quality System management with the company's annual and long-term objectives.

Good to Have:

• Experience with testing and certification of Active Medical Devices for IEC 60601 standards (basic and product family).
• Exposure to handling difficult audit/client scenarios with tact, diplomacy, and integrity.
• Ability to admit and correct errors while firmly upholding quality positions.
• Hands-on experience with electronic document management systems and digital QA tools.

Qualifications:

• Bachelors or Masters degree in Biomedical Engineering, Medical Electronics, or relevant field.
• Minimum 1 year experience with Quality Assurance/Quality Control in a medical device or regulated manufacturing environment.
• Knowledge of international medical device regulations and quality standards (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
• Certifications in Lean, Six Sigma, or Quality Management are an added advantage.

• Desired Skills:

• Strong analytical, organizational, and communication abilities.
• Proven project management and team collaboration skills.
• Proficiency with MS Office, QMS software, and audit tools.
• Assertive, detail-oriented, and able to work independently.