Quality Assurance Manager

Quality Manager – North America Nanosonics is seeking a Quality Manager. This is an onsite position. We improve the safety of patients, clinics, their staff and the environment by transforming the way infection prevention practices are understood and conducted and introducing innovative technologies that deliver improved standards of care. Nanosonics is a company that specializes in the development of innovative solutions for the automated reprocessing of reusable medical devices. Today, Nanosonics has a global presence with offices across Australia, Canada, the United States of America, Europe, the United Kingdom and Japan. Global HQ is located in Macquarie Park, Sydney, where all Research & Development, Manufacturing and Corporate functions reside. The US Corporate HQ is located in Indianapolis, IN. SPECIFIC RESPONSIBILITIES & ACCOUNTABILITIES: Our Core Values: Collaboration, Innovation, Discipline, Agility, Will to Win Quality System Management & Compliance Ensure the site’s quality processes comply with applicable global regulations (e.g., FDA QSMR, ISO 13485, MDSAP) and company QMS requirements. Implement and maintain site-specific quality procedures, ensuring alignment with global quality policies. Support internal and external audits, acting as the site’s primary quality representative during regulatory inspections and customer audits. Ensure timely and effective closure of audit findings, non-conformances, and CAPAs. Collaborate with the Global Quality team to implement QMS improvements that enhance operational efficiency and compliance. Conduct regular reviews to assess site-level compliance and identify opportunities for continuous improvement. Product Release & Control Oversee the product release process, ensuring that all finished goods meet product specifications, quality standards, and regulatory requirements before shipment. Review batch records, test data, and quality documentation to authorize product release. Manage product quarantine, rework, and rejection processes in collaboration with the Operations and Quality teams. Ensure traceability and accurate documentation of released products in line with regulatory expectations. Post-Market Surveillance & Complaint Handling Act as an extension of the Global Complaint Handling Unit (CHU) by supporting the intake, documentation, and escalation of complex or high-priority customer complaints from the North American market. Facilitate local complaint investigations when site-specific expertise, product analysis, or manufacturing insights are required. Collaborate with the CHU to provide additional technical data, manufacturing insights, and investigation outcomes as needed. Assist in gathering data to support complaint trending, root cause analysis, and reporting activities. Ensure accurate and timely communication between the site and CHU to support regulatory reporting obligations. Collaboration & Stakeholder Engagement Act as the primary quality liaison between the North American site and Global Quality leadership, ensuring seamless communication and alignment. Partner with the Site Operations Manager to embed quality processes into day-to-day site activities. Work cross-functionally with Engineering, Manufacturing, and Supply Chain teams to resolve quality issues and support continuous improvement initiatives. Provide quality guidance and training to site staff to ensure awareness of QMS requirements and promote a strong quality culture. Leadership & Team Development Provide leadership and mentorship to site quality staff, fostering a proactive and accountable quality culture. Develop and implement training programs to build quality awareness and improve staff competency in QMS processes. Promote a collaborative, solutions-focused approach to quality management across all site teams. SKILLS, KNOWLEDGE AND EXPERIENCE: 10+ years of experience in quality management within the medical device industry or a similarly regulated environment. Bachelor Degree in Engineering or Science Experience in Medical Device or Pharma preferred Experience in production of chemical products Strong knowledge of ISO 13485, FDA QSMR, MDSAP and other applicable regulatory standards. Proven experience managing product release, batch documentation review, and quality control processes. Experience supporting customer complaint investigations and collaborating with centralized complaint handling units. Experience representing a manufacturing site during regulatory audits and successfully managing audit responses. Strong understanding of QMS design, implementation, and improvement. Excellent communication skills with the ability to engage effectively with both operational teams and global stakeholders. What We Offer Competitive pay Medical, dental, and vision benefits with employer HSA contributions and FSA options Immediately vested 401K (US) with company match Paid Vacation, Holidays and Sick Time Make a difference in your community with 8 hours of Volunteer Paid Time Off each year, giving you the ability to support a cause or organization of your choice. Employer-paid short-term disability, long-term disability, and life insurance Robust Employee Assistance Program Tuition Reimbursement for eligible programs Opportunities to expand your skill set and share your knowledge across a ASX publicly traded, global organization Pay range and compensation package Annual salary $113,000 - $169,000 STI 10% Nanosonics is committed to fostering a diverse, inclusive, and equitable workplace where everyone feels valued and respected. We welcome applicants of all backgrounds and strive to ensure equal opportunities in recruitment, development, and advancement. We uphold the principle of equal pay for equal work and actively work to eliminate any unexplainable pay gaps. If you’re passionate about contributing to an environment where diversity thrives, we encourage you to apply. #J-18808-Ljbffr