Manager, Sustaining Quality Engineering - Shockwave Medical - Santa Clara California

Company: Disability Solutions
Location: Santa Clara, California
Posted On: 02/02/2025

Johnson & Johnson is recruiting for a Manager, Sustaining Quality Engineering (Hardware/Software) for Shockwave Medical Inc. located in Quality Santa Clara, CAAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/. \rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.\rAt Johnson & Johnson, we all belong.Position OverviewThe Manager, Sustaining Quality Engineering (HW/SW) provides leadership to the Sustaining Quality Engineering group and works closely with internal and external departments to efficiently deliver safe and effective medical devices to customers in compliance with Shockwave Medical (SWM) policies and procedures. This position will represent the hardware and software product life cycle management team. This position will support project teams to ensure that existing products are designed, developed and manufactured in accordance with customer, corporate, and regulatory guidelines and execute initiatives for continuity of supply chain, quality improvement, cost reduction, and product safety. This position provides Quality Assurance support to functions with a focus on process validation, process improvements, post market sustaining activities, and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366 and IEC 60601.Essential Job Functions

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• Oversee all aspects of sustaining quality activities as it relates to Hardware, Software and Systems engineering.
• Oversee and manage Quality Engineers and Technicians supporting sustaining quality engineering activities:
• Hire, support, and mentor direct reports to develop a highly effective team.
• Set goals for Quality personnel based on corporate objectives.
• Ensure Quality Personnel follow regulations and industry standards.
• Provide visible leadership and oversees daily activities.
• Develop and maintain budget.
• Provide support to Manufacturing and Operations (either at internal site or at external vendor site):
• Establish and maintain validated processes.
• Identify, drive, and implement process improvements.
• Participate in Supplier Quality activities including supplier selection and audits.
• Work with contract manufacturers to maintain product quality and resolve any non-conformances that arise.
• Support business scalability and continuous improvement projects.
• Actively participate in Design Control/Design Change/Supplier Change activities such as:
• Ensure design transfers to manufacturing are completed successfully and in a compliant manner.
• Maintain Risk Management File documents such as Risk Management Plan, ongoing Risk Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management Reports etc.
• Ensure Sustaining projects and Design/Supplier Change activities are performed in compliance to regulations, standards, and internal procedures.
• Draft/Review/Perform Hardware and Software Verification and Validation Test Plan, Test Protocols, Methods, and Reports.
• Audit DHFs to ensure compliance to relevant procedures.
• Subject matter expert on application of relevant standards, test sample sizes and usage of statistical techniques for sustaining and design/supplier/process change projects.
• Drive Standard Gap Assessment activities.
• Ensure compliance to new country requirements prior to product release.
• Investigate and document results for returned devices from clinical studies and commercial complaints.
• Maintain and manage the Servicing Program and coordinate servicing activities with internal and external parties.
• Support Finished Goods distribution and commercial operations Quality activities.
• Support and assist in maintaining compliance with other areas of the QMS as needed (Non-Conformance, Complaints, CAPAs, Post Market Surveillance, Management Responsibility, Supplier Controls, Audit Support, etc.)
• Analyze, review and present data for key Quality metrics to identify any significant trends.
• Initiate, review, and approve Document Change Orders (DCO.)
• Participate in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.)
• Support ongoing Regulatory submission activities and product approval processes.
• Participate in the implementation and continuous improvement of the Quality Management System.
• Provide technical support to the Quality inspection group.
• Other duties as assigned.\r\r More...

      

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