Quality Engineer

Job Description Summary

Performance QA activities to ensure compliance with applicable standards and medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Excellent understanding of applicable standards and regulations and industry practices with good auditing skills. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stated objectives.

Educational Background

Bachelor's degree in Engineering or related discipline

Professional Experience

Minimum 4 years

Job Description

Job Responsibilities

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• Leads QS activities, including the following:

• Ensures regulatory compliance for all aspects of QS processes
• Leads internal audit program
• Leads preparation of Quality Management Review material, prepares and shares meeting minutes and action items. Ensure timely completion of action items
• Leads planning and scheduling of QMS activities
• Lead the organization in third-party quality audits, ensure availability of documentation by following war-room concept, closes the loop with external auditors on audit reports, action plan, etc.

• Authors, reviews and provides input for QS documents to ensure compliance with QSR, ISO and EN requirements
• Leads continuous improvement of the QS
• Understands post-market surveillance and complaint handling process.
• Provides QS knowledge to organization as needed. Administers appropriate training as needed
• Reviews and improves existing quality procedure workflows and identifies areas of improvement for efficiency
• Shall independently author concise quality investigation reports with appropriate corrective action and preventive action identified
• Ensures document and record control per applicable standards and procedures

• Good working knowledge and auditing experience of medical device regulations and practices (ISO13485, FDA, QSR, etc.)
• Fair understanding of QA principles, concepts, industry practices, and standards. General knowledge of related technical disciplines

• Minimum 4 years relevant experience in quality management system and GDP compliance
• Disciplined and well-organized in documentation
• Team player with excellent interpersonal and communication skills
• Proven ability to work independently with a minimum of supervisor input
• Certified as a ISO13485 Lead Auditor

• Trained on 21CFR 820 requirements and ISO14971
• Demonstrated ability to quickly learn new subject matter
• Strong critical thinking
• Excellent communication and writing skills