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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 were 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 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:

• 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.

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:

• General knowledge in Quality Systems Regulatory requirements (ISO and/or cGMP regulations).

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 Internal employees contact AskGS to be directed to your accommodation resource.

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