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Quality Systems Manager
4 weeks ago
Quality Manager Location: Oak Creek, Wisconsin
Standard business hours, Monday–Friday.
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 medical 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.
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.
Product Quality & Compliance
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.
Leadership & Team Management
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.
Customer Feedback & Continuous Improvement
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.
Audits & Management Reviews
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
~ Deep understanding of ISO 13485, FDA 21 CFR 820 (QSR), MDSAP, and MDR quality system requirements.
~ Experience with 3D printing/additive manufacturing processes and familiarity with their quality control challenges.
~ 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.
~ No travel required.
Reports To: Plant Manager
