Quality Operations Manager

Operations Quality Manager
-On-site | Littleton, MA

Masis Staffing Solutions is seeking a senior, hands-on Operations Quality Manager to lead all aspects of manufacturing quality for proton therapy products. This role owns day-to-day quality execution on the manufacturing floor, drives robust quality systems, and leads continuous improvement initiatives to ensure safe, compliant, high-quality product output.

Reporting to the Director of QA/RA, the Operations Quality Manager will serve as the primary owner of manufacturing quality activities, partnering closely with Manufacturing, Engineering, Supply Chain, and Operations leadership. This role manages the QC Supervisor and Quality Engineers and is expected to be a visible leader on the production floor—able to quickly identify risk, drive root cause analysis, and implement sustainable corrective actions.

• Lead manufacturing-related quality activities across production operations.
• Ensure consistent application of shop-floor quality standards (in-process inspection, final inspection, release activities).
• Provide quality decision-making authority for product acceptance, deviations, and risk.
• Oversee Quality Control (QC) strategy, including inspection methods, sampling plans, and disposition processes.
• Own and govern the Nonconformance Report (NCR) process (investigation, disposition, closure).
• Analyze trends from NCR/MRB activity and feed learnings into CAPA and continuous improvement.
• Lead 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/products with quality planning and risk management.
• Manage and develop Quality Engineers, QC Supervisor, and inspectors; coach and mentor the team.

• Ensure compliance with FDA QMSR
  , ISO 13485
  , and applicable international regulations.
• Support internal/external audits (including FDA and notified body inspections).
• Drive effective execution of CAPA, risk management, and change control related to manufacturing.
• Partner with Manufacturing/Engineering/Supply Chain/Operations to embed quality into daily work.
• Support supplier quality activities tied to manufacturing performance and material quality.
• Provide clear, data-driven updates to leadership on quality performance, risks, and improvement plans.

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

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

• Ability to sit/stand for extended periods while performing computer-based work, testing, and reviews.
• Regular use of office equipment (laptop, phone, copier).
• Office environment with occasional work in labs and controlled factory settings.
• Ability to walk through manufacturing environments safely and follow site safety requirements.
• Occasional domestic/international travel may be required, 5-10%

Masis Staffing Solutions is committed to providing a workplace free of discrimination, harassment, and retaliation. We are an equal opportunity employer. Applicants, employees, and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation or transgender status), national origin, age (40 or older), veteran status, disability and genetic information (including family medical history).