Quality Compliance Specialist II- Shockwave Medical

At 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

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Quality Compliance Specialist II - Shockwave Medical to join our team located in Santa Clara, CA.

At 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/.

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 Quality Compliance Specialist supports Shockwave Medical’s processes for Quality including management of associated procedures ensuring compliance with regulatory requirements and industry standards.

Under supervision, may lead/support collaboration with various functional areas, partners with colleagues across Shockwave sites, to ensure compliance is established and maintained.

Provides support to quality system, quality system initiatives and audits of quality system.

Essential Job Functions

• Escalations Management
  • Coordinate and manage escalated quality issues from various departments.
  • Provide support in guiding thorough investigations for escalated issues.
  • Track and process issue stages and documentation.
• Field Actions
  • Support the planning and execution of field actions in response to quality issues.
  • Collaborate with cross-functional teams to ensure timely communication and resolution of field actions.
  • Monitor the effectiveness of field actions and report on outcomes.
• Quality Planning
  • Assist in the development and execution of quality plans that align with organizational objectives.
  • Track, monitor and report on quality plan status for the organization.
• Gap Assessments
  • Conduct/assist on standard gap assessments between current practices and alignment with industry standards and regulations.
  • Support the development strategies to close identified gaps in quality standards.
  • Collaborate with relevant teams to implement necessary changes and monitor progress.
• Stay updated on industry trends and regulatory changes affecting quality standards.
• Develop and maintains local standard operating procedures to follow all FDA/EU/ISO regulations, as well as Corporate quality standards and policies.
• Develop and provide training and support to staff on quality processes and improvement initiatives.
• Participate in cross-departmental quality improvement projects and initiatives, as needed. Support investigations/actions associated with non-conformances and CAPA.
• Address any ad-hoc quality-related tasks that arise to support continuous improvement efforts.
• Plan and coordinate quality events, including timelines, logistics and budgets.
• Support Quality department objectives to meet the organizational goals, quality system improvement initiatives as directed by Quality manager and performs other related duties as ass