Supplier Quality Engineer (Medical Device) - 24839

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Supplier 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.  

Strong attention to detail, validation experience required (IQ/OQ/PQ), position can be hybrid (1 day/week on site) 

Position Description (Principle Duties and Responsibilities)

Will work within the QA Shared Services Product Transfer Team, responsible for quality related activities as it applies to Product Transfer, these include but not limited to the following:

• Supporting all transfers globally, (Supplier to Supplier, Supplier to Our Client, Our Client to Supplier, Our Client Division to Division)
• Having knowledge of and ability to provide interpretation and guidance on Regulations, Corporate and Site Local procedures as they relate to quality activities such as FMEA, MSA's, Validations and Qualifications.
• Reviewing and approving of Validation/Qualification Documentation.
• Point of contact for quality for product transfers at Scoping, Planning and Execution phases
• Enable successful completion of product transfer to achieve its quality, cost and time requirements
• Provide expertise for at least 1 quality specialty associated with product transfer
• Be able to identify MT quality risks/gaps and provide solutions to correct
• Product Transfer Independent Reviewer as required
• Supports Product Transfer Process training where required
• Provides feedback to lessons learnt for each completed product transfer
• Drive continuous optimization of Product Transfer Process

Requirements

• Bachelor's Degree in Engineering or Science fields 
• Minimum of 2 years experience in manufacturing environment or equivalent. 
• Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards 
• Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment 
• Demonstrated working knowledge to positively influence Supplier Quality performance 
• Analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions 
• Ability to plan, organize and implement multiple concurrent tasks 
• Strong communication/ influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization. 
• Demonstrated ability to work in cross-functional team environments 
• Willing to travel in support of business needs to different geographical locations. 
• Good knowledge of continuous improvement methodologies 
• Preferred industries are Medical Device, aviation, aerospace, automotive and defense