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Quality Engineer II

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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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Ciudad Juarez, Chihuahua, Mexico

Job Description:

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

We are searching for the best talent for Quality Engineer II to be in Juarez, Salvarcar, Plant.

Purpose: Under general supervision, participate in new and sustaining product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices. Supports quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Will receive technical guidance on complex problems, but independently develops approaches and solutions. Work is usually well defined and is checked for progress and reviewed for accuracy upon completion

You will be responsible for:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

  • Primary responsibilities include assisting in a supporting role on new product development, sustaining and supply chain quality projects. Assist in the development of effective quality control and associated risk management plans.
  • Write 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).
  • Help to ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDR, and product is properly transferred to manufacturing.
  • Provide support in quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction
  • Assist in planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.
  • Support vendor audits as technical lead as needed and support Supplier Quality as Franchise
  • Primary responsibilities include creating reports & Dashboards focus in Quality solutions, Understanding data structures and digitalization principles. Logical thinking, assisting in a supporting role on new product development, sustaining and supply chain quality digital projects. Assist in the development of effective digital quality controls.
  • Write process and product validation protocols and reports, equipment qualifications, engineering, change orders.
  • Use digitals tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
  • Help to ensure that development activities follow design control requirements.
  • Support NC, CAPA, Internal Audit, Training and QS activities as needed and ensures compliance to all applicable due dates.
  • Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
  • Moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives.
  • Responsible for communicating business related issues or opportunities to next management level.

Qualifications:

  • Bachelor's degree in a related field, or research and development experience in a medical device or other regulated industry is required.
  • Office 365 Environmental (PowerApps, Power Automate, SharePoint
  • PowerBi
  • Databases Structures
  • Reporting & Dashboarding
  • American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
  • Familiarity of GD&T (Geometric Dimensioning and Tolerancing) concepts is desirable.
  • Ability to develop and implement Quality standards.
  • Some knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices.
  • Some knowledge of or education in Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
  • Ability to apply project management skills to fulfill new product development requirements.
  • Problem solving skills.
  • Verbal and written communication skills and ability to effectively communicate with internal and external personnel

Required Skills:

Preferred Skills:

Analytical Reasoning, Data Savvy, Detail-Oriented, Execution Focus, Human-Computer Interaction (HCI), Incident Management, Process Oriented, Project Management, Quality Assurance (QA), Quality Control (QC), Quality Processes, Quality Services, Quality Systems Documentation, Robotic Automation, Software Development Management, Software Reliability Engineering, Technologically Savvy, Test Planning