Quality Manager
Littleton, MA – $140-150K + bonus

Position Summary
We are seeking a senior, hands-on Quality Manager to lead all aspects of manufacturing quality for our high-complexity medical imaging and therapeutic systems. Reporting directly to the Director of QA/RA, you will serve as the primary owner of manufacturing quality affairs, responsible for day-to-day execution on the production floor, driving robust quality systems, and leading continuous improvement initiatives.
The successful candidate will work cross-functionally with Manufacturing, Engineering, and Supply Chain leadership. You must be comfortable making independent quality decisions while aligning with the broader corporate Quality and Regulatory strategy. This role manages the QC Supervisor and Quality Engineers and is expected to be a visible leader capable of identifying risk, driving root cause analysis, and implementing sustainable corrective actions.
Essential Functions

• Quality Leadership: Own and lead manufacturing-related quality activities across all production operations, ensuring consistent application of standards from in-process inspection to final release.
• Decision Authority: Provide strong quality decision-making regarding product acceptance, deviations, and risk management.
• Operational Oversight: Direct oversight of Quality Control (QC) activities, including inspection strategy, sampling plans, and disposition processes.
• Process Governance: Own the Nonconformance Report (NCR) and MRB processes; ensure trends are analyzed and fed into CAPA and continuous improvement efforts.
• Continuous Improvement: Lead manufacturing process improvement initiatives (Lean, Six Sigma) focused on quality, efficiency, and yield.
• Team Management: Manage and develop a team of Quality Engineers and QC staff, acting as a mentor to elevate the team’s technical capabilities.
• Compliance: Ensure all activities comply with FDA QMSR, ISO 13485, and applicable international regulations.
• Audit Support: Partner with leadership to support internal and external audits, including FDA and notified body inspections.

Required Education & Experience

• Education: Bachelor’s degree in Engineering (Mechanical, Electrical, or related technical field).
• Experience: 8+ years of progressive Quality experience specifically within medical device manufacturing.
• Leadership: 3+ years of experience managing Quality Engineers and/or QC teams.
• Technical Expertise: Deep experience owning NCR/MRB processes and shop-floor quality execution.
• Regulatory Knowledge: Strong working knowledge of ISO 13485 and risk-based quality principles.

Preferred Qualifications

• Experience with low-volume, high-complexity medical capital equipment (e.g., Radiation Therapy, X-Ray, CT, MRI, or similar large-scale systems).
• Lean Six Sigma certification.
• Experience driving cultural change and “quality-first” mindsets in a fast-paced environment.

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