Senior Engineering Clerk - Orthopedics Business

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 Manufacturing

Job Sub Function:

Manufacturing Assembly

Job Category:

Business Enablement/Support

All Job Posting Locations:

Juarez, Chihuahua, Mexico

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

About Surgery

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

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

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

"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 : Senior Engineering Clerk ​

Purpose:

You will be responsible for :

Perform NCR lifecycle documentation and investigation, using statistical concepts.

Provides technical support to identify the causes of non-conformances and process failures and to implement corrections thus assuring process performance and compliance against Ethicon’s QSR, GMP   and ISO requirements for the manufacturing process.

Performs non-conformance investigations including NCR origination, bounding, product control, failure

investigation, correction, and documentation with the non-conformance system.

Support engineers in performing validation activities, execution of protocols, engineering studies and   documentation.

Help Write engineering documentation (protocols, procedures, special instructions, reports, etc.)

Supports the documentation changes in compliance with Ethicon’s Change management system. Engineering support in the completion of projects mainly focused on quality improvements, cost/scrap  r eduction, increased capacity and New Products.

Conduct robust investigations. Analyzes data and recommends actions for process, equipment and system improvement.

Review all PLM System (Software solution used by Quality Systems to manage the document

control process) validation documentation to Complete VMP Action Tasks.

Update VMP logs with all applicable validation references, protocols, completion reports etc. that support the validated state of the validation components.

Generate and provide quarterly change orders to create, release, and revise VMP Procedures and VMP Logs.

Ensure all validation packages (group of a specific document class) involve the required documentation to support and assure the validated state of a validation component.Monitoring, tracking and assurance that the annual review activities are performed.

Ensure Validation Baseline/Periodic Reviews are completed on time.

Qualifications / Requirements:

Bilingual English/Spanish (Preferred).

Computer skills: Excel (including charts/graphs), Word, Internet Explorer.

Experience in medical device manufacturing environment. (Preferred)

Knowledge of medical product and process design concepts such development, materials, standardization

science and basic statistics. (Preferred)

Knowledge of word processing, spreadsheet analysis, presentation graphics, some engineering analysis and

some statistical software (Minitab preferred).

Analytical thinking to provide and lead product inquiry investigations.

Ability to work in a cross-functional team to complete projects, knowledge in PE tools such as Kaizen

Ability to solve basic problems using FI methodologies such as Five Whys, 5Ms, and others.

#LI-Onsite

Required Skills:

Preferred Skills:

Accountability, Agile Manufacturing, Agility Jumps, Communication, Equipment Maintenance, Good Manufacturing Practices (GMP), Issue Escalation, Manufacturing Equipment, OSHA Compliance, Plant Operations, Predictive Maintenance, Problem Management, Process Oriented, Professional Ethics, Project Management, Repair Management, Report Writing