Quality Assurance Manager

Quality Assurance Manager

The Quality Assurance Manager will lead the continuous development and maintenance of a Quality Management System (QMS) to ensure compliance with regulatory requirements, including ISO 13485 status, while also overseeing product quality assurance and risk assessment initiatives. This role collaborates with cross-functional teams to establish product and process quality specifications, to develop or drive improvements and to ensure compliance with regulatory bodies and local regulations. The QA manager will foster a culture of continuous improvement within the organization and an integration of the quality management system into every process and product aspect of the company's everyday activities to deliver products and services safely and to great customer satisfaction.

The ideal candidate for this role is a process-oriented individual with deeper analytical skills, strategic and collaborative leadership, possessing a deep understanding of quality management systems and key regulations such as IVDR and FDA, a meticulous attention to detail, a proactive approach to problem-solving, and a passion for delivering products that exceed customers' expectations.

What You'll Do:

• Total Quality Management System (TQMS): Develop, implement, and maintain a robust QMS to ensure compliance with regulatory requirements and internal standards. Oversee the continuous improvement of QMS processes, including documentation, supplier qualification, audits, and corrective/preventive actions.
• Team Leadership and Development: Lead and mentor the team, fostering a culture of continuous improvement and accountability. Provide training and development opportunities to enhance the skills and knowledge of the quality assurance team.
• Regulatory Compliance: Stay on top of industry regulations and standards related to manufacturing of products, including IVDR.
• Risk Assessment and Management: Implement effective risk mitigation strategies to minimize potential quality and safety risks throughout the supply chain. Collaborate with cross-functional teams to integrate mitigation strategies into overall operational practices.
• Customer Complaint Management and Investigation: Maintain a robust system for receiving, investigating & resolving customer complaints related to product quality and safety. Analyze complaint trends using statistical methods to gain insights to allow for targeted improvements. Ensure corrective actions are implemented and champion continuous improvement measures based on customer feedback.
• Implement Process Improvements: Execute ongoing projects of process improvements to address key quality and customer issues, and to engrain the QMS into the company activities.
• Product Quality Assurance: Oversee Quality Control process for products serving EU and US, collaborate with cross-functional teams to establish and enforce product quality specifications, ensuring consistency and adherence to brand standards. Conduct regular product quality inspections and lead investigations into any deviations from established standards.
• Supplier Quality: Work closely with product suppliers to establish and maintain high-quality materials. Develop and implement supplier quality assurance programs to monitor and improve supplier performance.
• Data Analysis and Reporting: Utilize data-driven insights to identify trends, areas for improvement, and opportunities for innovation. Prepare and present regular reports to executive leadership on quality metrics, compliance status, and improvement initiatives.

Key Experience We're Looking For:

• 6+ years of progressive experience in quality assurance with 3+ years of experience in a leadership (people management) role
• Bachelor's degree in a related field preferred
• Extensive knowledge of regulatory requirements, quality standards, and industry best practices related to IVD products
• Demonstrated experience in managing budgets, setting strategic goals, and delivering results in a fast-paced, dynamic environment
• Exceptional leadership and communication skills, with the ability to influence and inspire cross-functional teams to drive successful product safety and quality improvement initiatives
• Black Belt certified preferred
• Experience with ISO13485 certification

Perks of Working @ Novir:

• Competitive total compensation offerings
• Generous paid time off policy
• Medical, dental and vision insurance, some of which is covered by the company
• Company provided Disability and Life Insurance
• Flexible schedule and work from home policy
• A friendly office atmosphere in our office space in the heart of Milwaukee's Third Ward
• Opportunity to build something incredible while being surrounded by intelligent, hardworking and motivated coworkers