Staff Quality Systems Engineer

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:

Digital Quality

Job Category:

Professional

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

Johnson & Johnson MedTech is recruiting for a Staff Quality Systems Engineer in Quality Systems & Digital Services. The primary location for this position is Raritan, NJ; however, candidates may be located in any MedTech location (Including Cincinnati, OH, Raynham, MA, Warsaw, IN, West Chester, PA, Irvine, CA).

In MedTech Quality Systems & Digital Services Center of Service we strive to provide unparalleled, essential service and expertise, orchestrating end-to-end integration, simplification, efficiency and digital transformation, enabling our

MedTech Business Units to focus on meeting the needs of the customer.

A seasoned individual contributor, who works independently with minimal direction, this role will lead, enable, and support projects that deliver a fit for future focus through digitization & automation while driving simplification & efficiency for new and legacy application platforms within the Quality System application portfolio. The position engages teams across the MedTech business units and operating companies as well as Johnson & Johnson Technology and Technology Quality organizations to implement application improvements to meet the evolving business technology and digital roadmap to improve customer experience through innovation. Also supports computer system validation/computer system assurance and business operational readiness activities intended to ensure effective Quality System application implementations. This position will provide technical mentorship on sophisticated problems to other team members.

Key Responsibilities:

• Lead deployments for new applications and technology capabilities.
• Lead improvements and maintenance of existing applications such as user access management, configuration changes, process changes, Automated Intelligence, remediation, and validation.
• Understand business partner needs, evaluate current technologies, and facilitate translation into IT solutions while balancing tradeoffs and business impact to resolve system issues.
• Participate on multi-functional teams to integrate IT solutions to optimally meet the requirements of the Digital Quality Management System and customer/patient needs.
• Lead various projects as assigned by management (small improvements to large program deployments).
• Develops complex domain expertise for quality system applications and maintains standardized base business procedures and processes associated with PLM, Document Management, Quality Events (e.g. - CAPA, NC) for continuous improvement.
• Assists in the oversight and monitoring of business-critical issues and responsible for presenting business-related issues or opportunities to next management level.
• Designs systems to collect and provide feedback to ensure continuous improvement of the Digital Quality management system.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Performs other duties assigned, as needed.

Qualifications

Education:

• A Bachelor's Degree is required; a degree concentration in Computer Science, Engineering, Life Sciences, or subject area is an asset.

Experience And Skills:

Required:

• A minimum of 6 years of related work experience is required.
• Strong communication, teamwork, and problem-solving skills are required.
• Proven understanding of project management principles is required.
• Ability to analyze, balance and prioritize risk is required.
• Ability to prioritize customer and patient needs.
• Above average digital literacy (Overall Technology/Data Science capabilities: Robotic Process Automation, Machine Learning) and command of commonly used business applications (i.e. Microsoft Office) are required.

Preferred:

• Experience with EtQ, Learning Management Systems, Product Lifecycle Management, ERP systems would be an advantage.
• Understanding of SDLC and CSA processes
• Proven understanding of Quality Management System processes required by 21 CFR Part 820, ISO 13485:2003 & CFR Part 11 regulation is desired.
• Experience in the MedTech field preferred.

Other:

• Available for domestic travel up to a 10% of the time is required.

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 & 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,  external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$91,000-$147,200

Additional Description For Pay Transparency:

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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://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.