Quality Engineer

Johnson & Johnson•San Angelo, TX

1d•Onsite

About The Position

Johnson & Johnson MedTech is recruiting for a Quality Engineer, located in San Angelo, Texas. 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. 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.

Requirements

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.
English language proficiency (oral & written) is required.

Nice To Haves

General knowledge in Quality Systems Regulatory requirements (ISO and/or cGMP regulations).
Spanish proficiency (oral & written) is a plus.
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.

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.