Senior Quality Manager-Advanced Imaging

Philips•Bedford, MA

3d•Onsite

About The Position

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.

Requirements

Minimum of 8+ years’ experience in FDA regulated medical device environments, with a focus on Quality Management System (QMS) Compliance, and Design Assurance functions.
Proven experience in functional management of quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
Strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
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.
Extensive experience in leading audit readiness, serving as the primary quality representative for regulatory inspections, external audits, and interactions with regulatory authorities and notified bodies and ensuring timely, effective responses to internal audits, regulatory inspections, and external assessments.
Proven experience utilizing Quality KPI’s/Data Analysis to assess project/team performance and identify process and continuous improvement opportunities.
Extensive experience leading CAPA/Nonconformance activities, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
Minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Responsibilities

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.