Quality Manager
2 days ago
Position Overview The Quality Manager will play a critical leadership role in establishing and maintaining the Quality Management System (QMS) for a new state-of-the-art clear aligner manufacturing facility in Oak Creek, Wisconsin. This position is responsible for building the quality function from the ground up-ensuring all processes, systems, and personnel are aligned with FDA, ISO 13485, MDSAP, and MDR regulatory standards. The ideal candidate is a hands-on, strategic quality leader with a strong background in medical device manufacturing and 3D printing technologies, capable of fostering a culture of quality and continuous improvement within a growing organization. This is a full-time, on-site role with no travel required. Key Responsibilities Quality Management System (QMS) Development & Oversight
- Establish, implement, and maintain a comprehensive Quality Management System in alignment with ISO 13485, FDA 21 CFR Part 820, MDSAP, and MDR requirements.
- Ensure compliance with all applicable medical device regulatory standards and customer requirements.
- Develop and document quality processes, policies, and standard operating procedures (SOPs) to support production startup and scale-up.
- Lead the site's efforts to obtain and maintain relevant quality certifications and regulatory approvals.
- Oversee all product quality control and quality assurance activities from incoming inspection through final release of finished products.
- Review and approve product releases to ensure full compliance with specifications and regulatory requirements.
- Partner with production, R&D, and engineering teams to implement robust in-process controls and drive defect prevention strategies.
- Lead root cause investigations, CAPA development, and risk management activities to ensure effective and sustainable corrective actions.
- Build, mentor, and lead a growing team of 6-7 quality professionals.
- Provide training and guidance to ensure adherence to QMS requirements and promote a strong culture of quality and accountability.
- Collaborate closely with cross-functional leaders (Operations, Engineering, Supply Chain, and Regulatory Affairs) to drive quality alignment across the organization.
- Establish and maintain a customer feedback and complaint-handling system in accordance with regulatory requirements.
- Collect, analyze, and report post-market surveillance data to identify trends and guide continuous improvement initiatives.
- Conduct regular quality review meetings to assess product performance, customer complaints, and audit findings-developing actionable improvement plans.
- Lead internal quality audits and prepare for external audits from regulatory agencies and notified bodies.
- Drive management reviews by providing data-driven insights, key performance indicators (KPIs), and recommendations for system enhancements.
- Bachelor's degree or higher.
- 5+ years of progressive quality management experience in the medical device industry, preferably with Class II or III devices.
- Deep understanding of ISO 13485, FDA 21 CFR 820 (QSR), MDSAP, and MDR quality system requirements.
- Proven success in establishing or scaling quality systems in a new or expanding facility is highly preferred.
- Strong leadership, team-building, and organizational skills with the ability to thrive in a fast-paced start-up environment.
- Excellent communication, analytical, and problem-solving skills with a continuous improvement mindset.
- In-person, on-site role at the Oak Creek, WI facility.
- Standard business hours, Monday-Friday.
- No travel required.
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