Customer Quality Product Investigation Engineer Site Liaison

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:

Palm Beach Gardens, Florida, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for a Customer Quality Product Investigation Engineer Site Liaison, Orthopedics, located at a DePuy Synthes Site(s) at either: Warsaw, IN; West Chester, PA or Palm Beach Gardens, FL.

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

Purpose:

This role includes oversight of product investigation in a supporting capacity as an subject matter expert (SME) with responsibilities of providing product knowledge in conjunction with Medical Safety, Health Authority Reporting, Design Quality, R&D, procedure and regulatory requirements, and product investigation training.

You will be responsible for:

• Supporting complex complaint investigations requiring input/reviews from R&D, Quality, Manufacturing (External & Internal) and Material Testing.

• Providing clear and concise communication, status updates and actions as required as the point of contact with global cross-functional teams and local management
• Driving Customer Quality projects as a clear expectation to identify, define, and draft business cases in a supportive capacity and to lead the closure as the Customer Quality project owner along with directing supporting roles as defined/required.
• Supporting Escalations, QRB’s, NC’s, QSMR’s, etc assigned within Customer Quality. Support of coordinating material, design, and manufacturing analysis conducted by DePuy Synthes functions such as R&D, Materials Testing, Manufacturing and our external suppliers.
• Engaging and leveraging relationships with key SME’s within Medical Safety, R&D, Design Quality, Commercial Quality, Materials Testing, Manufacturing and our external suppliers.
• Supporting product complaint metrics to achieve Key Process Indicators (KPI’s) and Regulatory requirements.
• Seeking and enhancing potential signal identification that connects directly to our customer centric organization that supports improved overall business outcomes.
• Triage activities to identify, expediate and redirect priorities of complaint investigations.
• Co-owning of business metrics to support process and product performance.
• Supporting the management of external vendors such as decontamination, shipping services, etc. Audit support with front room and back-room support.
• Supporting the customer complaint systems in accordance with company and regulatory requirements.

Qualifications / Requirements:

• University/Bachelor’s or equivalent degree in Engineering
• Generally, requires 1-2 years work experience
• Demonstrated experience in failure analysis/investigation
• Knowledge of Orthopedic products and Complaint Management Systems

Preferred:

• Experience in the Medical Device industry or medical field

• Demonstrated knowledge of manufacturing principles and practices
• Knowledge of / experience with six sigma and other process excellence tools/methodologies (CQE, PEx Green Belt, etc....)
• Problem solver to implement measurable actions to drive a customer focused process
• Ability to Investigate customer complaints and critical thinker of the failure/root cause for product quality issues and concerns
• Ability to work collaboratively with coworkers across multiple functions and geographies
• Ability to perform duties in accordance with policies and procedures
• Ability to coach/train others (products, procedures, investigation technique)
• Ability to communicate documentation of complaint investigations and conduct of training, verbally and in writing
• Ability to work in stressful/fast-paced environment
• Ability to work and interact with co-workers to accomplish company goals in a team environment
• Analytical/Problem Solving Skills using critical thinking methodologies

Other:

• Up to 10% travel may 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:

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy