•Develop and implement an ISO compliant quality management system. •Prepare team for the successful completion of ISO certification audit, ensuring adherence to international quality standards.•Collaborate with R&D, manufacturing, engineering, and regulatory affairs teams to ensure product development and manufacturing processes are aligned with quality objectives and standards.•Establish risk management processes, including identification, assessment, and mitigation strategies for enhanced product safety and reduction of risks.•Implement internal audit program to monitor quality management system compliance.•Implement comprehensive quality training programs to enhance employees' understanding of quality standards, procedures, and regulations.

• Provide Quality leadership and set the quality standard for the expanding manufacturing site and organization.• Responsible for setting the overall strategies, tactics and directions of the site QA, Quality Operations, Quality Systems and Quality Design and Development departments.• Hold final accountability for and decision making on the matters relating to GMP compliance for the site in alignment with Senior Leadership.• Ensure that the site goals and objectives are accomplished. • Identify continuous improvement opportunities for the quality systems including complaint analysis, quality investigations, CAPA, supplier quality and change control.• Establish and implement quality metrics for monitoring system effectiveness and to enable the company team to make sound quality decisions and monitor continuous quality improvement.• Accountable for development of QA, Quality Operations, Quality Systems and Quality Design and Development budgets that support the corporate and departmental goals and objectives. Responsible for controlling the budget during the fiscal year.• Provide advice and counsel to the site Leadership Team on regulatory GMP compliance issues.• Provide site production leader additional insights and direction regarding risk management program.• Participate in quality auditing activities including external (regulatory body) audits, supplier audits, and internal company audits.• Oversee the preparation and submission of regulatory notifications and registrations as required by US and international standards to ensure compliance and timely approval for market release of new and existing products.• Mentor and develop staff members within the organization.

• Serve as the ADL and SDC expert on quality management systems and compliance, ensuring sites are supported through the implementation and effectiveness activities. • Design, establish, implement, and maintain a resource plan that fully supports the needs of the business to maintain a compliant QMS• Lead move from paper based QMS and through implementation of eQMS (MasterControl) • Serve as Management Rep in facility, host for Internal and External audits (FDA, ISO)• Lead and oversee the change management, CAPA, QMR, internal audit, and training functions for the organization.• Function as the Subject Matter Expert on the quality management system, change control, internal audits, and CAPA during external audits/inspections by regulatory authorities (i.e. Notified Bodies, FDA, etc.).• Drive continuous improvement and LEAN activities with the sites to improve efficiencies in execution of the QMS.• Function as the ADL champion for IT projects impacting the QMS function and/or systems.• Develop, establish KPIs and own the business Quality Management Review.• Ensure each site has an effective training program and maintains compliance with the regulations.

Develop and implement a Quality System for ISO 13485:2016 certification, implement a robust Design Control process to support the launch of CE-IVD products, manage the day to day execution of quality systems, build and foster a culture of Quality in a previously R&D/RUO environment, and continually improve and build on the quality system while maintaining compliance with applicable Quality System Regulations and ISO standards.

Responsible for the implementation and management/oversight of the quality assurance and quality improvement programs. Ensure that processes and standards comply with all relevant quality standards and regulations; conduct continuous improvement reviews/audits with regards to all relevant policies/procedures and implements corrective action as necessary.Manage, coordinate and administer all functions of the QA team to achieve company compliance and objectives and demonstrate continuous improvement. Provide constructive and relentless guidance to upper management in finding solutions for resolving quality concerns.

Responsible for the implementation and management/oversight of the quality assurance and quality improvement programs. Ensure that processes and standards comply with all relevant quality standards and regulations; conduct continuous improvement reviews/audits with regards to all relevant policies/procedures and implements corrective action as necessary.Manage, coordinate and administer all functions of the QA team to achieve company compliance and objectives and demonstrate continuous improvement. Provide constructive and relentless guidance to upper mangement in finding solutions for resolving quality concerns.

Develop and implement regulatory strategies in support of new product development, lead the company’s discussions with all external agencies, manage the day to day execution of quality systems and implements improvements to the quality system while maintaining compliance with applicable Quality System Regulations and ISO standards (13485 and QSR), lead and participate in audits (external and internal), and review and submit necessary documentation in support of regulatory filings such as 510(k)s.