Quality Engineer II (2nd Shift)

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 Assurance

Job Category:
Professional

All Job Posting Locations:
Ciudad Juarez, Chihuahua, Mexico, Juarez, Chihuahua, Mexico

Job Description:

EXPERIENCE AND EDUCATION

The Senior Quality Engineer plans, conducts and directs engineering

projects or studies including complete projects requiring advanced

knowledge of a specialized field.

They apply comprehensive and diverse

knowledge of engineering principles and practices within broad

assignment areas.

They may coordinate and direct activities of technical

support staff and are responsible for technical development of assigned

staff.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and

AFFILIATIONS

*

 Experience with implementation of risk mitigation is preferred.

 Knowledge of product/process Risk Management (FDA and ISO standards) is required.

 Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze

data and be able to present data that facilitates/drives decision making

 Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred

including Measurement System Analysis, SPC, DOEs, Reliability, etc.

 The ability to perform "hands on" troubleshooting and problem solving is preferred.

Decision making

based on standards, requirements, procedures and quality knowledge gained with experience.

 Basic communication of quality issues, escalations and investigations to different levels.

 Good technical understanding of manufacturing equipment and processes is required.

 Understanding of the NPI (New Product Introduction) process and Process Validation expertise is

preferred.

 A thorough understanding of GMP/ISO regulations and validation regulations is preferred

 Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the

position.

 

 

Required Skills:

 

 

Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)