Senior Quality Engineer

THE EMPLOYER
Take your career up a few notches with one of the largest global medical technology companies in the world which have active 65,000 employees.
THE JOB
As a Senior Quality Engineer, your roles and responsibilities will include:

• Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
• Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specifications, test methods process validation, etc.
• Contributes to the completion of specific programs and projects
• Independently determines and develops approach to solution
• Evaluate test methods used in project activities
• Ensure implementation of Pharmaceutical Systems' global procedures and standards for QE engineering activities
• Provide support to the internal, regulatory body, and customer audits and associated corrective actions.
• Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share
• Support customers with technical and compliance information related to the "device"

DESIRED SKILLS AND EXPERIENCE
The ideal Senior Quality Engineer would be someone with deep experience in many (if not all) of the following:

• Education : BS degree in Engineering, or other scientific discipline
• Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP
• Knowledge of design control principles.
• Good understanding of statistical methods for Quality Assurance
• General working knowledge of the six-sigma process methodology
• Experience in Quality Systems, Six Sigma Methodology, Validation, and FMEA/Risk Management.
• Knowledge and experience in manufacturing
• Good written and oral communication skills
• Excellent problem-solving and analytical skills
• Ability to handle multiple projects simultaneously in an unsupervised environment.
• Ability to thoroughly evaluate, clearly understand, and communicate all aspects of assigned project

We understand that even if you are a seasoned Senior Quality Engineer you may not have all the skills listed here. If you are good at what you do and have a willingness to learn, let's talk.
ADDITIONAL INFORMATION
Compensation: Based on Experience. One of the best in the industry
Minimum Education: BS degree in Engineering, or other scientific discipline
Minimum Experience: Minimum of 5 years of relevant experience (Medical Device/ Pharmaceutical)
Type of position: Full-time Permanent Position with benefits
Telecommute: No
Location: Franklin Lakes, New Jersey
Relocation accepted: No