Senior Quality Engineer

• Ensure Compliance: Oversee and ensure compliance with relevant medical device regulations, including ISO 13485 and FDA standards, to uphold the highest quality standards in organ preservation and transplantation technologies.
• Quality Management: Implement and maintain robust quality management systems to monitor and control processes throughout the product lifecycle, contributing to the overall quality assurance framework.
• Risk Management: Utilize effective risk management methodologies to identify, assess, and mitigate potential quality risks associated with my clients' products.
• Documentation Control: Manage and maintain accurate and up-to-date documentation related to quality processes, ensuring accessibility and adherence to regulatory requirements.
• Product Testing and Validation: Plan, coordinate, and execute product testing and validation processes to ensure the reliability and performance of my clients' medical technologies.
• Root Cause Analysis: Conduct thorough investigations into quality issues, employing root cause analysis methodologies to identify the underlying factors and implement corrective and preventive actions.
• Cross-Functional Collaboration: Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to address quality-related challenges and foster a culture of continuous improvement.
• Audits and Inspections: Prepare for and participate in internal and external audits, inspections, and assessments to verify compliance with regulatory standards and identify areas for improvement.
• Supplier Quality Management: Collaborate with suppliers to ensure the quality of incoming components and materials, implementing effective supplier quality management processes.
• Training and Development: Provide training and guidance to internal teams on quality-related processes, standards, and procedures, contributing to the ongoing professional development and awareness of quality requirements within the organization.

• Educational Background: B.S. Degree (Engineering or Technical)
• Experience: 4-5 years of experience working within Quality Engineering
• Class 3 Device Expertise: Proven track record of working with Class 3 medical devices, demonstrating a deep understanding of the heightened regulatory requirements and quality standards associated with these complex and critical healthcare products.
• ISO 13485 Proficiency: Extensive experience and proficiency in implementing and maintaining ISO 13485 quality management systems, ensuring adherence to international standards in the development and manufacturing of medical devices.
• Clean Room Experience: Demonstrated hands-on experience in working within clean room environments, showcasing the ability to maintain stringent cleanliness and hygiene standards critical to the production of high-quality medical devices.
• Regulatory Compliance: Strong familiarity with FDA regulations governing medical devices, with a history of successful interactions with regulatory bodies and a proactive approach to ensuring compliance in all quality-related aspects.
• Risk Management Mastery: Adept at applying advanced risk management methodologies, particularly in the context of Class 3 medical devices, to identify, assess, and mitigate potential risks throughout the product lifecycle.
• Root Cause Analysis Skills: Proven ability to conduct thorough root cause analysis to identify and address quality issues effectively, contributing to a culture of continuous improvement within the organization.
• Documentation Excellence: Skilled in managing and organizing comprehensive documentation related to quality processes, ensuring accuracy and compliance with regulatory requirements for Class 3 medical devices.
• Cross-Functional Collaboration: Strong interpersonal and communication skills, with a successful history of collaborating seamlessly with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to address quality challenges.
• Audit Preparedness: Experience in preparing for and participating in audits, inspections, and assessments related to Class 3 medical devices, demonstrating a commitment to maintaining the highest standards of quality and regulatory compliance.
• Continuous Learning and Adaptability: Demonstrates a commitment to continuous learning, staying updated on industry trends, advancements, and evolving regulatory requirements in the realm of Class 3 medical devices and clean room manufacturing. Additionally, showcases adaptability to the dynamic nature of the medical technology industry.

• Competitive Compensation
• Strong Healthcare & Wellness Benefits
• Retirement Plans
• Professional Development
• 401k Match

Michael Page