Senior Director, Quality & Compliance (Cardiac Assist)

Job Overview

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. This position is required to be onsite 4 days a week.

Job Responsibilities & Essential Duties

Quality Leadership & Strategy

• 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.

Quality Management System (QMS)

• 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.

Regulatory Compliance & Audit Management

• 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.

Quality Operations & Continuous Improvement

• 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.

Stakeholder Management & Talent Development

• 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.

Minimum Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required. Master's degree preferred.
• Minimum of 15 years of progressive experience in Quality Assurance, Quality Systems, or Quality Engineering within the medical device industry.
• Minimum of 5 years in a senior leadership role at the Director level or above.

Required Knowledge, Skills & Abilities

• Strong communication, presentation, and public speaking skills.
• Ability to build and maintain strong relationships with internal and external stakeholders.
• Strong influencing and collaboration skills across a matrixed organization.
• Proven ability to lead, coach, develop, and motivate teams.
• Demonstrated success leading in a cross-functional environment and driving organizational change.
• Strong decision-making, problem-solving, and strategic-thinking capabilities.
• Demonstrated experience developing and executing quality system strategies in highly regulated environments.
• Hands-on experience in Design Quality Engineering, Production Quality Engineering, Supplier Quality, CAPA, and Nonconformance Management.
• Experience supporting medical device manufacturing operations.
• In-depth knowledge of FDA medical device requirements, including 21 CFR Part 820 (QMSR), Part 803 (Medical Device Reporting), Part 806 (Corrections and Removals), and Part 7 (Recalls), as well as ISO 13485 and ISO 14971.
• Demonstrated, hands-on experience with FDA compliance and enforcement actions, such as consent decrees, warning letters, or other judicial or administrative actions, including leading or materially contributing to remediation and close-out.
• Proficiency in Microsoft Office applications, including Word and Excel.