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 factors validation are integrated into the product development process in alignment with FDA guidance and IEC 62366-1.
• Collaborate with cross-functional teams to plan and execute usability testing, ensuring that use-related hazards are appropriately identified, evaluated, and mitigated.
• Lead efforts in Test Method Validation (TMV) and Measurement System Analysis (MSA) to confirm reliability, repeatability, and reproducibility of test methods.
• Assess and interpret applicable standards (e.g., IEC 60601-1, ISO 11607, IEC 62304) and ensure appropriate application in design verification and testing documentation.

Software Quality (as applicable)

• Support and review software lifecycle deliverables and validations in compliance with IEC 62304 for embedded, standalone, and SaMD products.
• Collaborate with software developers and system engineers to ensure alignment between software requirements, risk mitigations, and verification activities.

Design Changes & Lifecycle Quality

• Lead QA review and approval of design changes, ensuring risk re-assessment, documentation accuracy, and traceability are maintained.
• Serve as the quality lead for Product Care Boards and support cross-functional reviews for change prioritization and impact analysis.
• Ensure ongoing maintenance and audit readiness of Design History Files (DHF) and Risk Management Files (RMF).
• Oversee Field Action activities, including the development of customer communications, execution of field action plans, response to regulatory authority inquiries, and oversight of field implementation activities to ensure timely and compliant resolution and formal closure with regulatory authorities.

CAPA, Audits & Quality System Readiness

• Lead or support product-related CAPAs, driving detailed root cause analysis, effective corrective actions, and follow-through on effectiveness checks.
• Represent Design Quality during internal and external audits, including FDA inspections, Notified Body reviews, and corporate quality audits.
• Ensure a state of continuous inspection readiness by enforcing documentation integrity and procedural compliance.

Supplier Quality & External Collaboration

• Participate in supplier selection activities, define quality requirements, and review supplier validation and PPAP submissions where applicable.
• Collaborate with Supplier Quality and R&D to ensure robust controls are in place for purchased components impacting design performance.

Performance Management & Team Development

• Establish team goals, performance expectations, and training plans aligned with department and organizational objectives.
• Mentor and develop quality engineers to deepen their regulatory knowledge, technical capability, and cross-functional collaboration skills.
• Support succession planning and staff development through coaching, delegation, and structured feedback.

Work special projects as assigned

Required Knowledge, Skills, and Abilities

• Bachelor’s degree in Engineering, Science, or a related technical field is required; Master’s degree preferred.
• A minimum of 15 years of progressively responsible experience in Quality Engineering, Quality Assurance, or Product Quality within the medical device or other regulated industry.
• Minimum 5 years of direct experience in Design Quality Engineering, with hands-on ownership of Design Controls and Risk Management processes.
• Demonstrated people management experience, including mentoring, team development, and performance oversight.
• Significant experience supporting design projects, Health Hazard Evaluations (HHEs), Field Actions, CAPA investigations, and post-market surveillance activities.
• Experience with emerging technologies in product design, software validation, or digital quality systems is highly desirable.
• Preferred to be Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Six Sigma Green Belt, Regulatory Affairs Certification (RAC), or ISO Lead Auditor certification.
• Strong working knowledge and application of FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, EU MDR, IEC 60601-1, IEC 62304, and IEC 62366-1.
• Proficiency in quality engineering tools and methodologies, including FMEA, fault tree analysis, TMV, MSA, DOE, and GR&R.
• Demonstrated experience in design verification and validation, including usability/human factors validation.
• Strong project management and leadership skills with the ability to manage multiple priorities and cross-functional teams.
• Effective cross-functional collaboration and the ability to influence R&D, Regulatory Affairs, Manufacturing, and Supplier Quality.
• Excellent analytical and problem-solving skills, with a continuous improvement mindset.
• Strong technical writing and presentation skills, with attention to detail and documentation integrity.
• High-level proficiency in Microsoft Office Suite and quality/statistical analysis tools such as Minitab.

Ideal Candidate Will Demonstrate

• Visionary leadership and ability to influence without direct authority
• A strategic mindset with comfort navigating ambiguity and time-sensitive regulatory decisions
• Passion for patient safety, engineering excellence, and global compliance
• Confidence in presenting to senior leadership and regulatory bodies
• A strong sense of ownership for product quality across the full lifecycle

Supervision/Management of Others

• This is a people management role with direct supervisory responsibilities over Quality Engineers supporting product development and sustaining projects.
• Responsible for coaching, performance management, and development of direct reports.
• Expected to lead improvement initiatives both independently and collaboratively across functions.

Internal and External Contacts/Relationships

• Regular interaction with internal stakeholders across all levels and functions, including R&D, Regulatory Affairs, Operations, Medical Affairs, and Supplier Quality.
• May engage externally with suppliers, auditors, consultants, and regulatory authorities as a representative of the Quality function.

The base salary for this position is a minimum of $185,000 and a maximum of $225,000 plus annual bonus of 25%

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About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.