Senior Manager Quality, Product Design (Wayne, NJ)

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

The Sr. Quality Manager – Product Quality Engineering & Design Quality is a key leadership position within the Quality & Regulatory Compliance (QRC) function, responsible for managing a team of quality professionals supporting both new product development and sustaining engineering initiatives. This role offers the opportunity to shape the future of product quality and compliance in a globally recognized medical device organization, with visibility to executive leadership and significant cross-functional impact. This position ensures the robust implementation, execution, and continuous improvement of design controls and risk management processes in accordance with global regulatory requirements and internal quality standards. The Sr. Quality Manager will serve as a strategic partner to R&D, Regulatory Affairs, Marketing, Customer Service, Medical & Clinical Affairs, Manufacturing, and other cross-functional teams, with a strong focus on influencing timely and compliant project execution. This includes ensuring rigorous application of design control requirements, development of verification and validation strategies, integration of risk management principles, and maintenance of design history files. The incumbent will also be accountable for ensuring compliance with applicable standards and regulations, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601-1, and IEC 62304, while fostering a culture of quality, collaboration, and operational excellence.

This position is office based 4 days a week.

 

Job Responsibilities and Essential Duties

Leadership & Strategic Influence

• Provide leadership, direction, and coaching to a team of quality engineers supporting both new product development and sustaining engineering activities.
• Serve as the primary Quality representative on cross-functional project teams, influencing the execution of critical quality deliverables in accordance with project timelines and regulatory expectations.
• Report to the Sr. Director of QA & Regulatory Compliance and serve as a key voice in quality-related business decisions, product lifecycle strategy, and design governance forums.
• Lead by example in fostering a culture of accountability, continuous improvement, and quality-first mindset.
• Collaborate with R&D, Regulatory Affairs, Manufacturing, Medical Affairs, and Supplier Quality to ensure seamless integration of quality requirements across the product lifecycle.

Design Quality & Compliance Oversight

• Own and continuously improve the Design Controls process in accordance with FDA 21 CFR 820, ISO 13485, EU MDR, and internal QMS requirements.
• Ensure proper traceability between design inputs, risk mitigations, design outputs, and verification/validation activities.
• Review and approve design documentation including plans, protocols, reports, and DHF elements to ensure accuracy, adequacy, and readiness for audit.

Risk Management & Health Hazard Evaluation (HHE)

• Establish and maintain robust product Risk Management Files (RMF) aligned with ISO 14971 and global regulatory expectations.
• Lead risk assessments and risk-benefit analyses throughout development and post-market, including integration of real-world performance data.
• Serve as lead or core team member for Health Hazard Evaluations (HHEs), ensuring sound technical rationale and documentation for field action decisions.
• Support to identify and trend complaint failure modes to drive proactive mitigation or corrective actions.

Verification, Validation & Test Method Compliance

• Oversee the development and execution of Design Verification and Validation (V&V) strategies, protocols, and reports, ensuring statistical rigor and traceability to user needs, design inputs, and risk mitigations.
• Ensure usability engineering and human