Design Quality Engineer II

Johnson & Johnson Innovative Medicine•Warsaw, IN

7d•Onsite

About The Position

DePuy Synthes is recruiting two Design Quality Engineer II team members for its Warsaw, Indiana location. The role applies basic Quality Engineering and scientific-method principles to daily work, along with relevant regulations, standards, and industry best practices. The engineer performs tasks on projects and assignments with technical responsibility or strategic input and receives intermittent, detailed instructions from technical Quality leaders and other stakeholders. The position supports product design reliability, investigations, test-method development, equipment/process/product qualifications and validations, and production and process controls. It also contributes to risk management, process improvement, technical reviews, and quality control planning. The role requires compliance with applicable laws, regulations, and company procedures, including health, safety, and environmental practices.

Requirements

Bachelor’s degree or equivalent in Engineering or a related technical/scientific field.
At least 2 years of related experience.
Basic knowledge of Quality Engineering and scientific methods and techniques.
Basic technical understanding of manufacturing equipment and processes.
Experience managing tasks or small projects and demonstrating project leadership abilities.
Basic understanding and application of measuring techniques, such as mechanical, optical, gages, and automation.
Ability to work in a stressful, fast-paced environment.
Ability to work and interact with coworkers in a team environment to accomplish company goals.
Management skills.
Analytical and problem-solving skills.
Verbal and written communication skills.
Knowledge of production and processing systems.
Knowledge of qualification and validation.
Knowledge of product design support.
Knowledge of quality statistics, data analysis, and tools.
Knowledge of product control and disposition.
Knowledge of product development support.
Knowledge of technical transfer and scale-up.
Knowledge of predictive analytics and reliability.
Ability to meet the stated position requirements of standing 15%, sitting 70%, and walking 15%.
Bloodborne pathogen safety test required.

Nice To Haves

Agility Jumps
Business Behavior
Compliance Management
Continuous Improvement
Database Backup
Data Gathering and Analysis
Data Savvy
Disruptive Innovations
Execution Focus
Issue Escalation
Process Oriented
Product Improvements
Quality Control (QC)
Quality Control Testing
Quality Management Systems (QMS)
Quality Standards
Regulatory Environment
Report Writing

Responsibilities

Apply tools and methods such as Six Sigma and Lean to identify and realize new product or process introductions and process improvements.
Apply risk-management and mitigation tools and practices, such as mistake proofing, critical control points, and failure mode and effects analysis.
Contribute to reliability assessments of product design.
Contribute to root-cause investigations using problem-solving techniques and tools, and assess the effectiveness of corrective actions.
Conduct and support development of test methods for equipment, process, and product qualifications and validations.
Ensure process quality control plans match product risk levels and are consistently followed.
Contribute to, implement, and/or maintain production and process controls using techniques such as process capability measures, statistical process controls, and process performance metrics.
Participate in technical reviews as appropriate.
Communicate business-related issues or opportunities to the next management level.
Follow applicable company health, safety, and environmental guidelines.
Ensure personal and company compliance with applicable federal, state, and local regulations, policies, and procedures.
Perform other duties as assigned.