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 Systems

Job Category:

Professional

All Job Posting Locations:

Irvine, California, United States of America, Plymouth, Minnesota, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

This is a hybrid role available in United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

We are searching for the best talent for Staff Quality Systems Engineer to be located in Irvine, CA or Plymouth, MN.

The Staff Quality Engineer provides high performance quality systems guidance and support for development, maintenance and enforcement of compliance with the company-wide quality management system. This position will have responsibilities in planning, implementing, execution, standardizing, coordinating, and managing QSMR Activities, CAPA, NC, product related Escalations, and Field Corrective Actions (FCA). The QS Engineer will collaborate closely with business partners to provide leadership with regard to Quality System standardization and execution activities to ensure activities are compliant with MD&D Sector, J&J Enterprise Standards and Quality Systems related training.

You will be responsible for :

• Serve as Quality Systems subject matter expert.
• Oversees Quality System metrics and coordinates efforts to maintain a healthy quality system performance.
• Track and report action plan status/completion as it relates to quality system improvement efforts.
• As needed, assist with creation and modification of Quality System procedures, work instructions and related documentation.
• While responsible for CAPA and NC systems, the QS Engineer monitors, and reports Quality Management System metrics to include supporting the Quality System Management Review and QPR.
• Can be assigned as Franchise site lead for CAPA and Non-conformance.
• Coordinate product issue assessments and Field Action execution.
• Lead Quality System Management Review process for either Site or Franchise level
• Works on complex investigations and coordinates technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, and subsequent closure of investigations.
• While responsible for the execution of the Product Escalation and Field Action, the QM Engineer is responsible for all Field Actions activities as Recall Coordinator – coordinate recall strategy plan definition with business stakeholders, coordinate periodic recall meetings with the Field Corrective Action (FCA) team, maintain meeting minutes, report status to internal departments and regulatory agencies, gather documentation of all activities and follow up recall activities to successful completion per established recall strategy.
• Responsible for managing and executing the issues escalations process to ensure critical/ significant quality issues impacting the product in the field are presented to the Quality Review Board for decision in containment/ corrections to be implemented for these in the field.
• Sees opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives
• Supports and participates in cross-functional projects when assigned/appropriate
• Facilitates technical innovations to enhance Quality systems and support business goals
• Support Audit Readiness and Execution for internal and external audits (e.g. Registrar, Notified Body, FDA, or customer audits)
• Facilitates training program
• Assesses and implements internal standards, external standards, and regulations, and tracks and influences others on the assessment of internal standards, external standards, and regulations

Qualifications

Education:

• Minimum of BS/BA required. A degree in engineering is preferred.

Experience

Required:

• A minimum of 4 years of related work experience within an FDA regulated industry.
• Previous work experience in a medical device industry.
• Working knowledge of 21 CFR Part 820, ISO 13485, and familiarity with ISO 14971
• Broad-based technical knowledge and experience to work effectively with others in diverse areas of business (Operations, R&D, RA, Field Service, Finance, Marketing/Sales)
• Ability to effectively prioritize and lead multiple activities

Preferred:

• Working knowledge of applicable requirements related to the MDSAP jurisdictions
• Working knowledge of 21 CFR Part 806
• Working knowledge in EU MDR requirements

Other:

• American Society for Quality (ASQ) CQE, CQA, CMQ/OE, CSSGBB, CSSBB, or equivalent professional credential is preferred
• Project Management Certification (example: PMI Certification, graduate certificate in program management, etc.) is preferred
• This position may require up to a 15% of domestic and/or international travel

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.

#LI-Hybrid

The anticipated base pay range for this position is :

$91,000 to $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

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.