Sr. Quality Product Owner Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Johnson & Johnson is hiring for aSr. Quality Product Owner Shockwave Medical to join our team located in Santa Clara CA.

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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.

Essential Job Functions

• 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.

Requirements

• Bachelors 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.

• Experience working in a medical devices regulated industry is preferred.

• 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.

An internal pre-identified candidate for consideration has been identified. However all applications will be considered.

Additional Information

• The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

• 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 Companys 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

• Additional information can be found through the link below. Skills:

  Preferred Skills:

  Analytical Reasoning Business Requirements Analysis Coaching Critical Thinking Human-Computer Interaction (HCI) Network Configuration Management Operating Systems (OS) Project Management Scripting Languages Software Development Management Systems Analysis Systems Development Systems Management Technical Credibility Technologically Savvy

  The anticipated base pay range for this position is :

  $91000.00 - $147200.00

  Additional Description for Pay Transparency: