Sr. Quality Product Owner - Shockwave Medical
About The Position
Johnson & Johnson is hiring for a Sr. Quality Product Owner – Shockwave Medical to join our team located in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Sr. Quality Product Owner in the manufacturing and product development industry plays a key role in supporting and optimizing quality application systems. This individual acts as the liaison between business stakeholders, IT teams, and engineering departments to ensure that quality processes support business goals, improve efficiency, and enable product innovation. The Quality Business Analyst will work in regulated environments such as medical devices, where adherence to standards is critical.
Requirements
- Bachelor’s degree (Computer Science, Computer / Software Engineering or equivalent preferred)
- 5+ years of relevant experience with 2+ years of experience as a quality business analyst working in an MFG IT environment and 2+ years of experience in a Business Analyst or similar role, with hands-on experience in Quality systems (e.g., Windchill, Teamcenter, Enovia).
- Knowledge of product development cycles, BOM management, change management, and compliance standards.
- Strong analytical skills with a continuous improvement mindset and attention to detail.
- Excellent communication skills, with the ability to work effectively with cross-functional teams.
- Familiarity with Agile or SCRUM project management methodologies is desirable.
Nice To Haves
- Experience working in a medical devices regulated industry is preferred.
- Familiarity with Agile or SCRUM project management methodologies is desirable.
Responsibilities
- Business Process Analysis & Documentation: Work with stakeholders to understand business processes, gather requirements, and develop detailed functional specifications and workflows.
- Quality System Support: Serve as the primary point of contact for troubleshooting quality issues and enhancements, ensuring system performance and data integrity across the organization.
- User Support & Training: Provide training to end-users, develop standard operating procedures (SOPs), and create process flow documentation to improve Quality systems utilization.
- System Enhancements & Optimization: Collaborate with the IT and engineering teams to implement new features, system updates, and customization that align with business goals.
- Cross-Functional Collaboration: Work closely with Manufacturing, and Quality teams to improve Quality applications workflows, ensure regulatory compliance, and enhance collaboration throughout the product lifecycle.
- Data Management & Reporting: Monitor Quality system data for accuracy and completeness, generate reports, and track key performance indicators (KPIs) to provide actionable insights to management.
- Change Management: Manage change requests and control updates to the quality system, ensuring proper validation and documentation of changes.
Benefits
- This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
