What are the responsibilities and job description for the Design Quality Engineer position at TekOne IT Services Pvt. Ltd.?
Job Title: Design Quality Engineer
Location: Middletown, VA
Duration: 5-6 months
Job Overview
We are seeking an experienced Senior Quality Assurance Design Engineer with a strong background in regulatory compliance and quality management systems for medical devices, particularly in IVDR 2017/746 and ISO 13485. The candidate will be responsible for supporting regulatory compliance, design control processes, and driving continuous improvement in the Quality Management System (QMS).
Key Responsibilities
Location: Middletown, VA
Duration: 5-6 months
Job Overview
We are seeking an experienced Senior Quality Assurance Design Engineer with a strong background in regulatory compliance and quality management systems for medical devices, particularly in IVDR 2017/746 and ISO 13485. The candidate will be responsible for supporting regulatory compliance, design control processes, and driving continuous improvement in the Quality Management System (QMS).
Key Responsibilities
- Regulatory Compliance: Apply and implement IVDR 2017/746 and ISO 13485 standards within the QMS. Assist in maintaining records and procedures to ensure compliance.
- Design History Files (DHF): Support the creation and maintenance of DHFs and design control processes.
- Audit Support: Participate in regulatory audits and certification inspections, ensuring compliance with established procedures.
- Gap Analysis: Conduct comprehensive compliance assessments, identify gaps, and propose improvement strategies.
- Action Plan Development: Implement strategies to address identified compliance gaps and monitor project execution.
- Training & Awareness: Lead compliance and quality training programs to enhance site knowledge and adherence to regulatory standards.
- Internal Audits: Support internal audit processes to ensure continuous operational compliance with regulatory requirements.
- QMS Enhancement: Continuously assess and enhance the QMS to align with regulatory updates and industry best practices.
- Reporting: Provide reports, analysis, and feedback on the QMS, focusing on leading indicators and key performance indicators (KPIs).
- IVDR and ISO Knowledge: Expertise in IVDR 2017/746 and ISO 13485 compliance.
- Design Control and DHF Experience: Proven experience with DHF creation and managing design control processes.
- Technical Expertise: Background in biology or chemistry, particularly for IVDR technical file remediation (paper-based documentation).
- Project Management: Ability to provide specific examples of managing procedures, mitigation strategies, and meeting project deadlines.
