Senior Director, Quality & Compliance (Cardiac Assist) Wayne, NJ
About the role
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.
The Senior Director, Quality & Compliance is responsible for leading the Quality and Compliance team in Cardiac Assist Product Area of Getinge’s Acute Care Therapy Business Function. This role provides strategic leadership and oversight for Quality Systems, Design and Production Quality Engineering, Quality Control. The position is accountable for ensuring compliance with applicable domestic and international regulations while driving operational excellence, continuous improvement, and a culture of quality across the organization.
Responsibilities
- Develop and lead a high-performing, accountable Quality organization positioned to support business objectives while maintaining compliance with applicable regulations, standards, and guidance.
- Develop and implement quality and compliance strategies across Design Quality, Production Quality, Quality Control, and Quality Systems functions.
- Establish and maintain a culture of quality, accountability, continuous improvement, and regulatory compliance throughout the organization.
- Manage departmental budgets and resources in support of business objectives.
- Ensure the Quality Management System (QMS) is effectively defined, documented, implemented, maintained, and continuously improved.
- Report on the performance and effectiveness of the QMS to executive leadership.
- Serve as Management Representative for the company Quality Management Systems.
- Maintain authority to place products or processes on hold when quality, safety, or compliance concerns exist.
- Lead quality audit programs, CAPA activities, nonconformance management, and corrective action implementation.
- Drive the implementation, harmonization, and continuous improvement of Quality System processes across the organization.
- Ensure business operations comply with applicable domestic and international regulations, standards, and guidance.
- Serve as the Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of EU MDR 2017/745.
- Lead and oversee regulatory inspections and third-party audits.
- Represent Quality functions during inspections and audits.
- Direct audit preparation activities and oversee audit responses and remediation plans.
- Prioritize and direct Quality Engineering and Quality Control activities supporting manufacturing operations, R&D programs, Supplier Quality initiatives, Sustaining Engineering projects, CAPAs, and continuous improvement efforts.
- Provide technical leadership and expertise in risk management, statistical methods, design controls, production controls, and quality system processes.
- Collaborate with cross-functional teams to establish and achieve quality objectives and performance metrics aligned with corporate goals.
- Drive process improvement and quality enhancement initiatives that improve compliance, operational efficiency, and product quality.
- Establish credibility and foster strong partnerships with internal and external stakeholders through effective communication and leadership.
- Lead, develop, and mentor the Quality leadership team, including staffing, succession planning, performance management, and employee development.
- Provide coaching, oversight, and technical guidance to engineering and quality personnel.