Quality Engineer II

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:

San Angelo, Texas, United States of America

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

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

We are searching for the best talent for Quality Engineer II position.

In collaboration with Operations and Engineering functions the Quality Engineer will be responsible for ensuring production of safe and effective products, while maintaining health authority and regulatory compliance.

You will be responsible for:

• Partners with business stakeholders using Quality Engineering tools to support new product development and sustain existing products, materials, and processes.
• Serve as the Quality representative on cross-functional product development teams.
• Support design controls and process validation for new products and product/process changes.
• Apply core QE methods (risk analysis, test method development, statistical analysis, sampling plans) to drive effective decisions.
• Lead development of product/process risk management plans and operating procedures.
• Investigate quality issues and oversee implementation of corrective and preventive actions (CAPA).
• Track and trend quality performance/issues and report insights to management and across sites.
• Advise project teams and suppliers to ensure compliance with company policies, procedures, and medical device regulations.
• Provide regulatory/standards expertise to ensure conformance with ISO, FDA, and other health authority requirements within the quality system.
• Support business excellence initiatives (e.g., Lean and Six Sigma) and act as an SME during internal/external audits, while ensuring HSE and broader regulatory compliance.

Qualifications / Requirements:

Education

• A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required; an advanced degree is an asset.

Experience and Skills

Required:

• A minimum of 0-2 years of Quality Engineering work experience is required, with experience in the medical device, pharmaceutical or other highly regulated industry preferred.
• General knowledge in Quality Systems Regulatory requirements (ISO and/or cGMP regulations).
• Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
• Candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Purchasing, Marketing and Medical Affairs.
• Good communication and presentation skills.
• Maturity and ability to display a high level of professionalism.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
• Strong skills in data analysis using Excel (pivot tables, trending, reporting) (commonly expected across QA roles)
• Experience with databases or data management tools [jooble.org]
• Familiarity with electronic Quality Management Systems (eQMS) or similar systems
• Ability to use reporting tools, dashboards, and documentation systems

Preferred:

• Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation.

Other:

• May require up to 10% travel.
• An ASQ certification (CQE, CQM, CRE or CQA) is an asset.
• Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
• English language proficiency (oral & written) is required; Spanish proficiency (oral & written) is a plus.
• 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

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.

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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