Quality Systems Engineer

Responsibilities

• Maintain, enhance, and ensure the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820.
• Support internal and external audits, oversee document control and CAPA processes, and drive continuous improvement initiatives.
• Collaborate with cross-functional teams to identify and implement quality system improvements, ensuring alignment with regulatory requirements and industry standards.
• Act as a role model and ensure safety is built into the QMS and work processes.
• Develop, implement, and maintain Quality Management System (QMS) processes to ensure compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820.
• Ensure compliance with ISO 13485 and 21 CFR Part 820 by providing regulatory guidance, conducting gap analyses, and leading corrective actions to close compliance gaps.
• Design and improve quality assurance and control procedures, continuously optimizing the QMS to enhance regulatory compliance.
• Investigate and resolve non-conformances, implementing corrective and preventive actions (CAPA) to mitigate risks and improve product quality.
• Lead or participate in internal audits, identifying gaps and implementing necessary improvements to maintain audit readiness.
• Apply problem-solving methodologies to prioritize and resolve quality issues promptly.
• Utilize Six Sigma and other quality tools to reduce process variation and enhance product quality.
• Monitor quality data and trends, providing recommendations to reduce defects and improve quality performance.
• Provide training to employees on quality system requirements to ensure compliance and consistency across departments.
• Collaborate with cross-functional teams to drive continuous improvements and optimize the effectiveness of the QMS.
• Aid in preparing for and supporting external audits, inspections, and regulatory assessments, ensuring that the company remains audit ready.
• Drive quality system enhancements, identifying and implementing improvement opportunities across the organization.

Qualifications

• A Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field.
• 3-5 years of experience in quality system management within a medical device or other regulated environment.
• Strong knowledge of FSSC 22000, ISO 9001, ISO 13485, 21 CFR Part 820, and industry best practices for QMS.
• Proficient in CAPA processes, risk management strategies, and both internal and external audit processes.
• Demonstrated ability to use QMS software and document control systems to manage regulatory documentation.
• Excellent problem-solving, analytical, and troubleshooting skills.
• Strong verbal and written communication abilities, capable of interacting with all levels of the organization.
• Experience with Six Sigma or other process improvement methodologies to drive quality enhancements.
• Ability to work collaboratively in cross-functional teams to ensure successful quality initiatives and improvements.