Sr Quality Compliance Specialist Shockwave Medical

Johnson & Johnson; Santa Clara (CA); On-site; USD 89,000 - 143,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Quality Compliance Specialist for its Santa Clara team. This role involves ensuring quality compliance in accordance with regulations and standards. Candidates should possess a Bachelor’s degree and extensive experience in quality system activities within the medical device industry. Key responsibilities include data analysis, assisting audit activities, and maintaining compliance records to ensure product quality.

Benefits

Medical benefits

Dental benefits

Vision benefits

Life insurance

Disability insurance

401(k) retirement plan

Vacation time up to 120 hours

Sick time up to 40 hours

Qualifications

• 5+ years of related experience in quality systems in the medical device industry is required.
• Working knowledge of FDA 820 QSR and ISO 13485.
• Experience with audit preparation and quality compliance activities.

Responsibilities

• Review production and sterilization records; assist in maintaining quality compliance.
• Participate in internal and external audit activities.
• Compile and monitor process control data and assist in quality metrics.

Skills

Knowledge of cGMP

Data compilation

Presentation skills

Document writing skills

Organizational skills

Time management skills

Communication skills

Multi-tasking abilities

Education

Bachelor’s degree

Tools

MS Word

MS Excel

QAD

Job description

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 Senior Quality Compliance Specialist to join our Quality 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/.

Shockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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

In compliance with FDA, European MDD/MDR & ISO regulations, the Senior Quality Compliance Specialist will perform work under general supervision. General scope of this position is to assist in maintaining quality compliance, assisting audit activities, review of lot history records, processing of non-conforming reports, maintaining data logs, assisting with External Standards management process, supporting audit activities and compiling quality metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

· Review production and sterilization records and release of final product to inventory

o Review production Records for accuracy and good documentation practice and compliance to respective Shockwave Medical procedures.

o Communicate with various functions (e.g., Production, Materials, QA, QE, etc.) in a professional manner to gather additional information.

o Compile and monitor process control data.

o Prepare reports from data collected for trending purposes.

· Assist with audit preparation activities, conduct and follow up of internal and external audits

o Participate in quality system activities and support internal and external audits as requested

o Coordinate audit related activities (prepare documents, track audit requests, take notes, schedule conference room, setup communication channels, etc.)

o Communicate with Subject Matter Experts regarding the audit requests.

· Assist with External records management process

o Assist in managing compliance to the current revisions of the standards.

o Coordinate standard related activities (track current revisions of the standards, follow up with standards owners on the status of implementation activities, maintenance of Standards tracker, etc.)

o Gather information and update as needed to ensure compliance with Shockwave Medical procedures.

· Assist with quality metrics for trending purposes

o Collect and log data as requested.

o Assist in preparation of presentations as needed for data analysis purposes.

· Assist in maintaining the NCR System

o Assist in managing overall compliance of the NCR system.

o Work cross-functionally with other teams to track and manage NCR activities from initiation through closure.

o Identify and implement NCR system continuous improvement activities.

· Perform QA related data entry and generate reports as required.

· Work cross functionally with other teams to collect information, follow up on tasks, etc.

· Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.

• Other duties as assigned.

Qualifications

• Bachelor’s degree and 5+ years of related experience performing Quality System related activities in the medical device industry.
• Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems.
• Proficiency in data compilation, analysis, presentation, and document writing skills.
• Excellent written and verbal communication skills.
• Excellent organizational skills.
• Experience with computer-based applications (MS Word, MS Excel, QAD).
• Strong time management skills and the ability to multi-task in a fast-paced environment.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.

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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$89,000 – $142,600

Additional Description for Pay Transparency:

This job posting is anticipated to close on March 12, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications. 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)). 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 The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.