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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.

Additional Information:

• The anticipated base pay range for this position is $89,000 to $140,185 annually.
• 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)).
• 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 of 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.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.