Quality Engineer II - Third Shift

About the role

Johnson & Johnson is hiring a Quality Engineer II for its third shift in Ciudad Juarez, Chihuahua, Mexico. Working under general supervision, you will join new and sustaining product and process teams to help develop quality-engineered systems and products, and support design verification tests, process validations and quality processes that comply with the company's Quality System policies and external standards such as FDA, ISO 13485, CMDCAS and PMDA.

Key responsibilities

• Support new product development, sustaining and supply chain quality projects, and help write quality control and risk management plans
• Write process and product validation protocols and reports, equipment qualifications and engineering change orders
• Use statistical tools (Six Sigma, SPC, DOE) to analyze data, make acceptance decisions and improve process capability
• Ensure development follows design control requirements, products meet applicable standards and the European Essential Requirements of the MDR, and products are properly transferred to manufacturing
• Support quality improvement, product acceptance planning (inspection instructions, equipment and gauge requirements, sampling plans), vendor audits and supplier quality
• Support NC, CAPA, internal audit, training and quality system activities, initiate and investigate CAPAs, and assist in complaint analysis
• Support Regulatory Affairs with submissions for process changes, inspection changes and new processes or devices

Required profile

• Bachelor's degree in a related field, with at least 2-4 years of quality, manufacturing or R&D experience in a medical device or other regulated industry
• Master's degree preferred
• Ability to develop and implement quality standards, and to apply project management skills to new product development
• Problem-solving skills and verbal and written communication skills with internal and external personnel

Required skills

• ASQ certification, Six Sigma experience and/or knowledge of process excellence tools is desirable
• Familiarity with GD&T (Geometric Dimensioning and Tolerancing) is desirable
• Knowledge of GMP and QSR requirements for medical devices, and of quality engineering, design control and V&V tools and methodologies