Quality Engineer

Our client is a leading innovator in the medical device industry, dedicated to improving healthcare outcomes through cutting-edge technologies. They are seeking a highly skilled and motivated Quality Engineer specializing in Design Assurance to join their dynamic team. As a Quality Engineer, you will play a critical role in ensuring the quality and regulatory compliance of their medical devices throughout the design and development lifecycle.

Key Responsibilities:

1. Collaborate with cross-functional teams including R&D, Regulatory Affairs, and Manufacturing to establish and maintain design control processes in compliance with applicable regulations and standards (e.g., FDA QSR, ISO 13485).
2. Lead and participate in design reviews, risk assessments, and design verification/validation activities to ensure product performance, safety, and efficacy.
3. Develop and implement quality plans, protocols, and reports for design verification/validation testing, including statistical analysis and documentation of test results.
4. Conduct thorough root cause analysis and corrective/preventive action (CAPA) activities to address design-related issues and non-conformities.
5. Support regulatory submissions by providing quality documentation and evidence of design control compliance.
6. Drive continuous improvement initiatives related to design processes, quality systems, and product quality.

Qualifications:

• Bachelor's degree in Engineering or related field; advanced degree (e.g., MS, PhD) preferred.
• Minimum of 5 years of experience in Quality Engineering within the medical device industry, with a focus on design assurance and design control processes.
• Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant quality standards.
• Experience with risk management methodologies (e.g., FMEA, fault tree analysis) and design validation/verification activities.
• Proficiency in quality tools and techniques such as statistical analysis, root cause analysis, CAPA, and quality management systems (e.g., QMS software).
• Excellent communication, collaboration, and problem-solving skills.

Benefits:

• Competitive salary and benefits package
• Opportunities for professional development and career growth
• Collaborative and innovative work environment
• Impactful work contributing to improving patient outcomes and healthcare industry advancements

If you are passionate about quality engineering, design assurance, and making a difference in healthcare, we invite you to join our clients team and contribute to their mission of delivering innovative medical solutions with uncompromising quality and safety.