Quality Engineer

Quality Engineer

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 tasked with developing and implementing methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed

 Key Responsibilities:

• Providing quality engineering support in quality assurance, control, and preventative activities within operations and other business functions.
• Developing and implementing methods and procedures for process control, process improvement, testing, and inspection to ensure that the products are free of flaws and function as designed.
• Advocating for and leading the execution of initiatives and projects to enhance quality performance within the business, while ensuring compliance with regulations and standards.
• Supporting product transfers and supplier change requests by coordinating necessary activities and documentation.
• Managing the Production Part Approval Process (PPAP) to verify and approve new or modified parts.
• Leading validation projects for new equipment and processes introduced to the plant.
• Developing, executing, and obtaining approvals for First Article Inspection (FAI) strategies.
• Creating and updating Standard Operating Procedures (SOPs) and inspection plans through the change management system.

What you need 

• Bachelor's Degree in Biomedical, Mechanical Engineering, or a related field.
• Relevant experience in medical device manufacturing or a regulated environment.
• 1+ years of industry experience in quality engineering or a related field.
• Strong knowledge of Change Management and Quality Management Systems (QMS).
• Excellent communication skills, both written and oral.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Demonstrated problem-solving and analytical abilities.
• Ability to build strong stakeholder relationships.
• Self-starter with efficient multitasking skills in a fast-paced environment.
• Experience with validation activities and change control processes.
• Knowledge of engineering and quality concepts/ theories.