Senior Quality Manager-Advanced Imaging

## Senior Quality Manager-Advanced Imaging Apply locations:
Bedford, Massachusetts, United Statestime type:
Full time posted on:
Posted Yesterday job requisition :
589235### Job Title Senior Quality Manager-Advanced Imaging###

Job Description The Senior Quality Manager-Advanced Imaging provides leadership for the Quality Management System (QMS) and Design Assurance functions, ensuring the delivery of safe, effective, and compliant Image Guided Therapy products throughout the product lifecycle.
** Your role:
*** Lead the Quality functions as a strategic member of the leadership team, fostering a culture of quality, compliance, and continuous improvement across the organization.
* Provide oversight of the Quality Management System (QMS), ensuring compliance with applicable global regulations and standards, including FDA QMSR, ISO 13485, European Medical Device Regulation (MDR), and other regulatory requirements.
* Serve as the primary quality representative for regulatory inspections, external audits, and interactions with regulatory authorities and notified bodies.
* Establish, maintain, and continuously improve quality processes, systems, and procedures to ensure the delivery of safe, effective, and high-quality products.
* Lead and develop a high-performing quality organization through effective talent acquisition, performance management, coaching, succession planning, and employee development.
* Monitor and analyze quality system and product performance metrics, driving data-based decision making and strategic improvement initiatives.
* Partner cross-functionally with R&D, Operations, Regulatory Affairs, and other functions to resolve quality issues, support business objectives, and ensure effective execution of quality strategies.
* Oversee design assurance activities throughout the product lifecycle, including design controls, verification, validation, design transfer, and process validation.
* Ensure robust application of risk management principles across product development, manufacturing, and post-market activities to proactively identify and mitigate risks.
* Lead complex investigations, root cause analyses, CAPA activities, nonconformance management, and corrective actions to drive sustainable quality improvements.
* Integrate customer feedback, reliability data, and post-market surveillance insights to enhance product quality, safety, performance, and regulatory compliance.
* Drive audit readiness across the organization and ensure timely, effective responses to internal audits, regulatory inspections, and external assessments.
* Lead strategic quality and operational excellence initiatives utilizing quality engineering, Lean, Six Sigma, and other continuous improvement methodologies.
* Establish and manage departmental objectives, budgets, resource plans, and performance goals to ensure efficient and effective execution of quality responsibilities.
** You're the right fit if:
*** You have a minimum of 8+ years’ experience in FDA regulated medical device environments, with a focus on Quality Management System (QMS) Compliance, and Design Assurance functions.
* You have proven experience in functional management of quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
* You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21

CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
* You have extensive experience managing design assurance activities throughout the product lifecycle, including design controls, Risk Management (ISO 14971, DFMEA/PFMEA) V&V, design transfer, and process validation.
* You have extensive experience in leading audit readiness,…