Design Quality Engineer II

Biopharma Asia; Warsaw (IN); Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

Johnson & Johnson, DePuy Synthes is recruiting two Design Quality Engineer II for the Warsaw, IN location. The role applies quality engineering methods to daily tasks, supporting regulatory compliance and process improvements within a leading orthopedic business.

You will work under guidance from quality leaders, participating in risk management, product design support, and process controls to ensure robust manufacturing, testing, and validation practices.

Qualifications

• Bachelor’s degree in Engineering or related field with 2+ years of experience.
• Basic knowledge of quality engineering methods and techniques.
• Basic understanding of manufacturing equipment and processes.
• Experience managing tasks or small projects and showing leadership.
• Familiarity with measuring techniques (e.g., mechanical, optical, gages, automation).

Responsabilités

• Apply Six Sigma and Lean to identify and realize product or process improvements.
• Contribute to reliability assessments of product design.
• Lead root-cause investigations and corrective actions.
• Develop test methods for equipment, processes and product qualifications/ validations.
• Ensure quality control plans align with product risk levels and are followed.
• Communicate business-related issues or opportunities to management.

Connaissances

Quality engineering

Project leadership

Six Sigma

Risk management

Statistical analysis

Process controls

Manufacturing knowledge

Formation

Bachelor’s degree in Engineering

Outils

Quality software

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Warsaw, Indiana, United States of America

Job Description:

Depuy Synthes is the largest, most innovative, and comprehensive orthopaedic business in the world.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

DePuy Synthes is recruiting for two new Design Quality Engineer II team membersfor our Warsaw, IN location.

Applies basic Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments. Participates in and performs tasks on projects and assignments with technical responsibility or strategic input. Receives intermittent, detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.

DUTIES & RESPONSIBILITIES*

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

• Demonstrates competency to apply various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process improvements.
• Demonstrates competency to apply various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, and effects analysis).
• Contributes to the reliability assessments of product design.
• Contributes to root cause investigations using various problem solving techniques and tools, and assesses effectiveness of corrective actions.
• Conducts, and supports the development of, test methods in equipment, process, and product qualifications/validations.
• Ensures that process Quality control plans are in accordance with product risk level and are consistently followed.
• Contributes to, implements, and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).
• Participates in technical reviews as appropriate.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION*

• Bachelor’s degree (or equivalent) in Engineering or related technical/scientific field AND 2 or more years related experience.
• Basic knowledge of Quality Engineering/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 of and application of measuring techniques (for example, mechanical, optical, gages, automation

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Production and Processing Systems
• Qualification and Validation
• Product Design Support
• Quality Statistics, Data Analysis and Tools
• Product Control and Disposition
• Product Development Support
• Technical Transfer & Scale Up
• Predictive Analytics / Reliability

ADDITIONAL POSITION REQUIREMENTS

• Ability to work in stressful/fast paced environment
• Ability to work and interact with co-workers to accomplish company goals in a team environment
• Management Skills
• Analytical/Problem Solving Skills
• Ability to communicate verbally and in writing

Position Requirement

• Standing (__15_%)
• Sitting (__70_%)
• Walking (_15__%)

SAFETY TESTS

• Bloodborne Pathogen

Preferred Skills

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