Sr Quality Engineer

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

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Job Description:

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

We are searching for the best talent for Sr Quality Engineer to be in Juarez City.

You will be responsible for:

• Primary responsibilities include working in Quality Engineering and with other functional groups in support of new product/process development, quality operations or quality assurance.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.
• Develop and establish effective quality control and support associated risk management plans.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
• Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.
• Ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential
• Appendix I 100612422 Rev M CONFIDENTIAL use pursuant to Company Procedures Page 3 of 5
• Requirements are met per the MDR, and product is properly transferred to manufacturing.
• Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, part qualifications, specification development, and sampling plans.
• Support vendor audits as technical lead as needed and support Supplier Quality as Quality representative as appropriate.
• Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
• Assist in complaint analysis as appropriate.
• Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
• Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Consults with supervisor and provide guidance as needed concerning unusual problems and developments.

Qualifications / Requirements:

• Bachelor’s degree in a related field, along with a minimum of 4 – 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master’s degree is preferred
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
• Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is desirable
• Ability to develop and implement Quality standards.
• Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.
• Thorough knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
• Ability to apply project management skills to ensure fulfillment of new product development requirements.
• Demonstrated auditing and problem-solving skills.
• Understanding of Six Sigma and Business Excellence tools and methodologies. Lean manufacturing experience desirable.
• Ability to train and mentor a diverse array of employees on quality topics.
• Good understanding of theoretical and practical fundamentals and experimental engineering techniques