Quality Systems Project 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:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson Surgery Quality Systems is recruiting for a Quality Systems Project Engineer, located Raritan, NJ or Blue Ash, Ohio.

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

The Quality Systems Project Engineer supports the Ethicon Quality System by driving CAPA/NC data analysis, promoting robust failure investigations, and advancing quality improvement initiatives. In partnership with the MedTech Quality Business Enablement and E2E Productivity & Innovation Q&C, this role actively drives projects that enhance Quality System effectiveness, compliance, and operational performance. The position monitors quality system processes and metrics, serves as a coach and advocate for quality excellence, and collaborates across the Ethicon Franchise to support the harmonization and integration of optimized Quality System processes.

Key Responsibilities:

• Serves as a Quality Systems SME, tracking and reporting CAPA/NC action plans while supporting effective failure investigations, root cause analysis, and Quality System improvement efforts.
• Provides training regarding Quality Management System Elements (including, but not limited to CAPA, NC, DRB, Management Review, Quality Planning, Quality Manuals & Metrics) to representatives from other functional areas.
• Partners with E2E Productivity & Innovation Q&C and the MedTech Quality Business Enablement team to support Quality projects and initiatives that improve Quality System effectiveness, compliance, and operational performance.
• Manages cross-site citizen developed applications, ensuring proper maintenance according to the Master Validation Plan.
• Facilitates or supports meetings (including, but not limited to CAPA, NC, DRB, Management Review, Quality Planning, Quality Manuals & Metrics)
• Monitors and reports Quality Management System metrics.
• Works on complex investigations and coordinates technical teams and leads cross functional teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, Non-Conformance, and subsequent closure of investigations.
• Identifies opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
• Supports, participates, and leads in cross-functional projects when assigned/appropriate.
• Provides audit support for 3rd Party Inspections (e.g. Registrar, Notified Body, FDA, or customer audits).
• Completes assessments for internal and external standards and regulations across Ethicon sites
• Processes document changes in applicable document management systems as needed including maintenance of Franchise Quality Manuals and Quality Planning procedures.
• Provide leadership on optimization and harmonization Quality projects across Ethicon.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications

Education:

• A Bachelor of Science or equivalent degree in Engineering, Sciences, or Business Analysis is required.

Experience and Skills:

Required:

• Minimum of 4-6 years of experience working in an Operations, Manufacturing, Quality and/or Engineering role
• Experience working in an FDA regulated environment
• Strong communication, human relation, problem solving and analytical skills
• Demonstrated skills in root cause analysis and failure investigation
• Ability to communicate effectively with all levels of management and functions is required
• Experience in dealing with audits/ inspections with the FDA, other notified bodies or any other Health Authority

Preferred:

• Demonstrated Project Management skills with a strong results orientation
• Strong in ability to build collaboration, partnership and teamwork across local and global organizations
• Demonstrated proficiency in problem solving skill sets and good analytical skills
• Demonstrated leadership skills without direct authority responsibility
• Demonstrated effectiveness as a team member and a team leader

Other:

• Ability to travel domestically up to 10% 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.

Required Skills:

 

 

Preferred Skills:

Agility Jumps, Analytical Reasoning, Analytics Dashboards, Coaching, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, System Audits, Systems Analysis

 

 

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

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