Sr. Quality Engineer (EU-MDR)

Quality Engineer (EU-MDR)

12-Month+ Contract | 1st Shift | Monday-Friday, 8:00 AM-5:00 PM ET | Hybrid w 3 days a week onsite

Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Quality Engineer for a 12-month+ contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail-oriented Top Talents in an extremely collaborative and professional environment.  

As a Senior Quality Engineer, you will provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions.
 
 You will be specifically tasked with supporting EU-MDR initiatives for a portfolio of products. To do so you will develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are compliant to applicable regulations, free of flaws and function as designed.

 Key Responsibilities:

• You will be specifically tasked with supporting EU-MDR initiatives for a portfolio of products. To do so you will develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are compliant to applicable regulations, free of flaws and function as designed.
• You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulations and standards.

What you need 

• Bachelor's Degree - Biomedical Engineering, Mechanical Engineering or related field
• 4 + years of experience in industry required
• Experience supporting EU-MDR programs
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Firm understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.
• Excellent communication skills and attention to detail.
• Good understanding of engineering and quality concepts / theories.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
• Be willing to work as part of a multi-site team.
• Have knowledge of Risk Based and statistical concepts is desirable.
• Problem solving and analytical skills.
• Be able to build strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
• Ability to be the voice of Quality when dealing cross functionally.
• Excellent English (both oral and written).
• Up to 10% travel may be required