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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:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Principal Quality Compliance Software Specialist - Shockwave Medical t o 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 Principal Quality Compliance Software Specialist supports Shockwave Medical’s process for non-product software development life cycle (SDLC) including associated procedures for non-product software compliance assessments and validation of non-product software, ensuring compliance with regulatory requirements and industry standards. Supports project plans as QA representative when cross-functional support is needed.

Leads/supports collaboration with various functional areas, partners with colleagues across Shockwave sites, to ensure GxP compliance for non-product software applications are established and maintained. Supports establishing and maintaining the validation master plan for non-product software applications for Shockwave.

Serves as Shockwave’s non-product software SME and supports Shockwave sites in this role, as needed.

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

Provide support for the investigation and actions to address audit findings, nonconformances and corrective actions to further improve the quality system.

Support and/or participate in various cross-functional teams to align quality system with requirements (internal/external) and/or initiatives for quality system improvement, as directed.

Essential Job Functions

• Responsible for the process of non-product software development life cycle (SDLC) including associated procedures for non-product software compliance assessments and validation of non-product software. Supports project plans as QA representative when cross-functional support is needed. (50%)

• Leads/supports collaboration with various functional areas, partners with colleagues across Shockwave’s sites, to ensure GxP compliance for non-product software applications are established and maintained. Supports establishing and maintaining the validation master plan for non-product software applications for Shockwave.

• Develops and maintains local standard operating procedures to follow all FDA/EU/ISO regulations, as well as Corporate quality standards and policies

• Serves as process SME for Shockwave’s non-product software development life cycle (SDLC) during internal and external audits (20%)

• Serves as non-product software SME for Shockwave and supports Shockwave sites in this role, as needed. (10%)

• Supports Quality departments objectives to meet the organizational goals, quality system improvement initiatives as directed by Quality manager and performs other related duties as assigned by management (10%)

• Supports quality systems audits (internal and external) including follow-up support on investigations and actions taken to address audit findings. Supports investigations/actions associated with non-conformances and CAPA, as directed by Quality manager. (10%)

Requirements

• Bachelor’s degree in relevant life science, computer science, software engineering, or relevant discipline.

• Six (6) years of GxP software validation or similar experience in a GxP manufacturing or similar production environment

• Experience must be inclusive of at least three (3) years leading GxP software validation projects.

Required Knowledge:

• Quality Systems

• Working knowledge of non-product software GxP requirements and experience in non-product software validations.

• Knowledge of quality system requirements including familiarity with US FDA 21 CFR Part 820 & Part 11 and ISO13485 requirements. Knowledge of GAMP and EU Annex II.

• Knowledge of where/how external standards (ISO, etc) and external regulatory requirements are applicable to quality management system and/or product design/development and product regulatory submissions.

• Use of applications/systems which support our quality system such as document management system, change control, nonconformance, CAPA, audit, metrics reporting systems, software used in manufacturing/process, including Inspection/Measurement/ Test equipment software and/or firmware.

• Ability to work independently and/or collaboratively to complete work assignments and tasks.

• Ability to analyze validation and production data to assess compliance with GxP requirements and/or troubleshoot compliance problems

• 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)

• Employee 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.

Pay Transparency:

• The anticipated salary range for this position is $105,000 - $169,050

• 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 corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s 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 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.

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

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.

The anticipated base pay range for this position is :

$105,000 - $169,050

Additional Description for Pay Transparency: