Operations Quality Manager

Overview

Mevion is seeking a senior, hands-on Operations Quality Manager to lead all aspects of manufacturing quality for our proton therapy products. This role is responsible for owning day-to-day quality execution on the manufacturing floor, driving robust quality systems, and leading continuous improvement initiatives that ensure safe, compliant, and high-quality product output. Reporting directly to the Director of QA/RA, this individual will serve as the primary owner of manufacturing quality affairs.

The successful candidate will bring deep experience working cross-functionally with Manufacturing, Engineering, Supply Chain, and Operations leadership, and will be comfortable making quality decisions independently while aligning with overall Quality and Regulatory strategy. This role manages the QC Supervisor and Quality Engineers, and is expected to be a visible leader on the production floor, capable of quickly identifying risk, driving root cause, and implementing sustainable corrective actions.

• Own and lead manufacturing-related quality activities across all production operations.
• Ensure consistent application of quality standards on the shop floor, including in-process inspection, final inspection, and release activities.
• Provide strong quality decision-making authority related to product acceptance, deviations, and risk.
• Direct oversight of Quality Control (QC) activities, including inspection strategy, sampling plans, and disposition processes.
• Own and govern the Nonconformance Report (NCR) process, ensuring timely investigation, disposition, and closure.
• Ensure trends from NCRs and MRB activities are analyzed and fed into CAPA and continuous improvement efforts.
• Lead manufacturing process improvement initiatives focused on quality, efficiency, yield, and risk reduction.
• Apply Lean, Six Sigma, or similar methodologies to improve process capability and product quality.
• Support introduction of new equipment, processes, and products with appropriate quality planning and risk management.
• Manage and develop a team of Quality Engineers and QC Supervisor and inspectors.
• Act as a mentor and coach, elevating the overall capability of the manufacturing quality team.
• Ensure manufacturing quality activities comply with FDA QMSR, ISO 13485, and applicable international regulations.
• Partner with QA/RA leadership to support internal and external audits, including FDA and notified body inspections.
• Ensure effective execution of CAPA, risk management, and change control processes related to manufacturing.
• Work closely with Manufacturing, Engineering, Supply Chain, and Operations to ensure quality is embedded in all activities.
• Support supplier quality activities as they relate to manufacturing performance and material quality.
• Provide clear, data-driven communication to leadership on manufacturing quality performance, risks, and improvement plans.

• Bachelor’s degree in Engineering (Mechanical, Electrical, or related).
• 8+ years of progressive Quality experience in medical device manufacturing.
• 3+ years managing Quality Engineers and/or QC teams.
• Experience owning Manufacturing Quality, NCR/MRB processes, and shop-floor execution.
• Strong knowledge of ISO 13485, and risk-based quality principles.
• Demonstrated independent decision-making in fast-paced manufacturing environments.

• Experience with low volume, high complexity medical device products (e.g. Radiation Beam Delivery, X-Ray, CT, MRI, etc.).
• Lean Six Sigma certification.
• High-mix, low-volume manufacturing experience.
• Experience driving cultural change around quality.

• Must be able to sit or stand for extended periods of time while performing computer-based work, testing, or reviews.
• Regular use of standard office equipment including laptop, phone, and copier.
• Typical office environment with occasional work in engineering labs and controlled factory settings.
• Must be able to walk through manufacturing and factory environments safely, adhering to site safety requirements.
• Occasional travel, both domestic and international, may be required to support vendor engagement, customer site troubleshooting, and system compatibility testing.

The hiring range represents what Mevion Medical Systems, Inc. reasonably expects to pay for this position at the time of posting. The actual salary offered will depend on the selected candidate’s qualifications, experience, skills, and other job-related factors.