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.
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**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:
Johnson & Johnson MedTech is recruiting for a Quality Engineer, located in San Angelo, Texas.
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
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.
Key Responsibilities:
- 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
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).
- Ability to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, and Engineering.
- Good communication and presentation skills.
- Maturity and ability to display a high level of professionalism.
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.
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