Quality Engineer II

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions 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 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 companys 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:

• Bachelors 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

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