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 assigned by management.
• Support quality systems audits (internal and external) including follow-up support on investigations and actions taken to address audit findings.

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

Requirements

• Bachelor’s degree in relevant discipline.
• Three (3) years of experience in a GxP manufacturing or similar production environment.

Required Knowledge

• Knowledge of quality system requirements including familiarity with US FDA 21 CFR Part 820 & Part 11 and ISO13485 requirements.
• Ability to work independently and/or collaboratively to complete work assignments and tasks.
• Manage time, assignments, projects and tasks in a methodical manner to ensure scheduled and planned deliverables are completed on-time and accurately.
• Strong technical writing and computer skills
• Excellent communication, leadership, and problem-solving abilities
• Flexibility to support and manage multiple assignments and associated tasks.
• Supportive of innovation, customer-focused improvements, and participating in such efforts.
• Ability to work in a fast-paced environment while managing multiple priorities
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Employees may be required to lift objects up to 25lbs or more. Employees will be required to work in an air-conditioned office space and possibly perform some tasks in our non-temperature-controlled warehouse space.
• Travel: May require travel (up to 10%) to support business, as needed.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

 

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

 

 

The anticipated base pay range for this position is :

$75,000.00 - $120,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Company’s long-term incentive program.



Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year



Additional information can be found through the link below.

https://www.careers.jnj.com/employee-benefits