Hi,
My name is Sravani Dasari, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Quality Engineer position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows.
Job Title: Quality Engineer
Location: West Valley City, UT
Duration: Long Term
Position Overview
We are 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. This role requires hands-on experience developing and executing quality engineering activities while ensuring compliance with applicable regulatory requirements.
Key Responsibilities
• 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.
Required 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.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
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