You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
About The Role
We are looking for an experienced Digital NPD Quality Manager to lead Quality and Compliance activities for digital product development within Biosense Webster's innovation organization. In this role, you will partner closely with R&D, Operations, and cross-functional teams to ensure that digital solutions are designed, developed, and maintained in compliance with applicable quality, regulatory, cybersecurity, and privacy requirements throughout the product lifecycle.
This is an exciting opportunity to influence the development of cutting-edge digital healthcare solutions while driving quality excellence, compliance, and continuous improvement across the organization.
Key Responsibilities
Lead Quality and Compliance activities for digital product development programs.
Ensure compliance with design control requirements throughout the product development lifecycle.
Manage and maintain Design History Files (DHF) and conduct quality reviews and audits.
Partner with R&D, Operations, and cross-functional stakeholders to support the development and commercialization of digital solutions.
Provide quality oversight for cloud-based and software-enabled medical device products.
Review and approve quality and compliance requirements for external partners and subcontractors.
Drive Risk Management activities, including risk assessments, FMEA reviews, and mitigation planning.
Participate in Design Reviews and product release approval processes.
Ensure compliance with software development standards, cybersecurity requirements, privacy regulations, and quality system requirements.
Drive investigations, CAPA activities, defect reviews, and issue escalation processes.
Develop, implement, and continuously improve quality processes and procedures.
Provide leadership and mentoring to Quality Engineers and contribute to the growth of the Quality organization.
Present quality metrics, risks, and project updates to senior leadership.
Qualifications
Required
Bachelor's degree in Engineering, Quality, Statistics, Computer Science, or a related technical field.
Several years of experience in Quality Engineering and/or Quality Management within a regulated industry.
Experience supporting New Product Development (NPD) programs.
Strong understanding of design controls, risk management, and quality systems.
Experience working in cross-functional environments with R&D and Operations teams.
Excellent communication and stakeholder management skills.
Fluent English, written and verbal.
Preferred
Experience within the medical device industry.
Experience supporting software, cloud-based, or digital health solutions.
Knowledge of cybersecurity and privacy requirements for connected medical products.
Experience with ISO 27001 and software quality standards.
Experience leading audits, CAPAs, and quality improvement initiatives.
Desired Competencies
Strategic thinker with strong business acumen.
Results-oriented with a continuous improvement mindset.
Strong leadership and people management capabilities.
Ability to manage multiple priorities in a dynamic environment.
Excellent analytical and problem-solving skills.
Attention to detail while maintaining a big-picture perspective.
Self-driven, collaborative, and highly motivated.
Additional Information
Hybrid work model available
Travel: Up to 15% domestic and international travel
At Johnson & Johnson MedTech, we are driven by innovation and committed to transforming patient care through breakthrough technologies and digital solutions. Join us and help shape the future of healthcare.
Required Skills
Preferred Skills:
Business Behavior, Coaching, Controls Compliance, Cross-Functional Collaboration, Developing Others, Engineering, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, ISO 9001, Leadership, Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Team Management
