Principal Quality 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is hiring for a Principal Quality Engineer to support the ABIOMED business, to be located in Danvers, Massachusetts or Raritan, NJ. This is a DURATION BASED project expected to last 12 months.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

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

ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work.

Position Overview

The Principal Quality Engineer (Quality Engineering) serves as an expert individual contributor and assists with the development and management of Service and Repair Quality.  Ensures effective deployment of best practices in line with regulatory compliance requirements and needs.  Communicates with senior management on key metrics including overall Service & Repair Risk Management, adequacy of the CAPA, the potential impact of identified risks, and actions taken to mitigate risks.  Evaluates methods to ensure alignment with quality priorities for the Service & Repair system. 

Responsible for supporting and ensuring the effective deployment of Corrective Action and Preventive Action (CAPA) requirements for Service & Repair.  Interacts with the CAPA escalation board and Risk Management Board.  Responsible for results in terms of conformance to global compliance regulations, quality policies and standards.  Ensures effective development, deployment, maintenance, and improvement of the Corrective Action and Preventive Action (CAPA) Management and Risk Management within Service and Repair.  

Guides junior colleagues through consultation and mentoring in techniques and processes and provides functional (matrix) supervision.  Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.

Key Responsibilities

• Partner with design teams to ensure compliance with ISO 13485 and applicable regulatory requirements.
• Support the overall Service and Repair Risk Management and CAPA as a Subject Matter Expert (SME).
• Responsible for supporting CAPA and Risk Management systems and procedures in Service and Repair, working with cross-functional teams to ensure effective deployment of the CAPA and Validation processes. 
• Interact with compliance review and escalation boards as needed.
• Understand and assure conformance to global compliance requirements and regulations.
• Collaborate with CAPA owners to ensure timely resolution of work plans.
• Provide expertise and J&J best practices.  Connects Abiomed process owners with J&J SMEs and enables additional support as needed.
• Identify and report action plan progress, risks and interdependencies to senior management, sponsors, and stakeholders as needed.
• Lead workshops to tackle opportunity areas.
• Participate in design reviews to provide an independent perspective on compliance and risk.
• Provide quality oversight to ensure test strategies, acceptance criteria, and sample sizes.
• Lead or support test method validation (TMV) activities to ensure methods are suitable for their intended use and comply with internal and regulatory expectations.
• Ensure manufacturing processes, controls, and validations support design intent and regulatory requirements.
• Participating in FDA, Notified Body, and ISO 13485 audits/inspections
• Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Perform additional duties as assigned.

Qualifications

Education:

• Bachelor’s degree in Biomedical/Mechanical or related Engineering discipline is required.

Experience

Required:

• 6-8 years of related experience
• Experience in the medical device industry
• Demonstrated ability to independently interpret and apply applicable medical device quality system and regulatory requirements as they relate to design and development activities, including ISO 13485, ISO 14971, 21 CFR Part 820 / FDA QMSR, and EU MDR (2017/745)
• Demonstrated ability to manage multiple complex activities simultaneously while maintaining attention to detail and compliance.
• Acts as a Principal-level technical authority, providing coaching and informal mentorship to Senior and mid-level Quality Engineers and influencing cross-functional decision-making.
• Self-directed and accountable, with the ability to independently execute assigned responsibilities and follow through on commitments.
• Experience supporting regulatory inspections and audits (FDA, Notified Body, ISO) through preparation, participation, and response development.
• Knowledge of ISO and cGMP regulations is required.
• Experience in documentation generation, performing and overseeing CAPA and Service & Repair processes.
• The ability to perform "hands on" troubleshooting and problem solving is required.
• Strong influencing skills are required.
• Ability to drive timely decisions with sometimes minimal data required.
• Ability to shape, creating a future vision and gaining support and alignment to that vision.
• Capability to facilitate a meeting or discussion.
• Ability to zoom in on detail when required and zoom out to see the overall big picture as needed.
• Effective working in a matrix organization
• Must have ability to lead efforts aimed at the identification of problematic situations or risks, interdependencies, risk escalation, and mitigation.
• Analytical and critical thinking skills are essential.
• Excellent organizational and time management skills

Preferred:

• Experience supporting development of Class II or Class III medical devices, preferably within cardiovascular or interventional product areas.
• Experience contributing to quality activities supporting regulatory submissions (e.g., 510(k), CE Technical Files)
• Hands-on experience with EtQ systems (e.g., CAPA, NC)
• Experience supporting remediation activities and manufacturing readiness.

Other:

• Lean, Six Sigma or Design for Six Sigma certification is preferred
• Up to 25% travel will be 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.

Required Skills:

 

 

Preferred Skills:

Coaching, Controls Compliance, Critical Thinking, Engineering, Fact-Based Decision Making, Financial Competence, ISO 9001, Lean Supply Chain Management, Non-Conformance Reporting (NCR), Organizing, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application

 

 

The anticipated base pay range for this position is :

$102,000.00 - $177,100.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits