Quality Engineer

Job Title

Key Responsibilities

Required Qualifications

Stark Pharma Solutions Inc. is seeking an experienced Quality Engineer to support new product development, design quality, and remediation initiatives within a medical device environment. The ideal candidate will possess strong technical expertise in traceability matrix verification (TMV), risk management, verification and validation (V&V), and design integration activities.

• Support new product development and design quality activities throughout the product lifecycle.
• Develop and execute traceability matrix verification (TMV), risk management, and verification & validation (V&V) activities.
• Participate in design integration and design remediation initiatives to ensure product quality and regulatory compliance.
• Support Design History File (DHF) remediation and documentation updates.
• Implement Design for Manufacturing (DFM) principles and support risk management architecture.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance.
• Ensure compliance with FDA Quality System Regulations and internal quality procedures.
• Contribute to continuous improvement initiatives and quality system enhancements.

Preferred Qualifications

• Bachelor's Degree in Engineering or a related technical discipline.
• 4+ years of Quality Engineering experience within the medical device industry.
• Experience in New Product Development (NPD) and Design Quality activities.
• Strong knowledge of FDA 21 CFR Part 820 and medical device quality system requirements.
• Hands-on experience developing and executing TMV, Risk Management, and Verification & Validation (V&V) activities.
• Experience with Design Integration, Design Remediation, and Design History File (DHF) remediation.
• Knowledge of Design for Manufacturing (DFM) principles and risk management methodologies.
• Experience with vascular medical devices such as catheters, stents, guidewires, or related products is highly preferred.