Duration: 12 months
Location: Bothell, WA
As a Quality Assurance (QA) Engineer, you will be responsible to audit Clients Supplier Controls processes, provide recommendations for continuous improvements and remediate open audit findings or observations. You will also be responsible to collaborate across functional areas (R&D, Manufacturing, Procurement, etc.) to provide support for FMEA development, establishing Critical to Quality (CTQ) characteristics as well as communicate key characteristics of components to suppliers.
• Audit Clients processes to ensure proper execution, CGMP and record creation
• Interact in corporate systems to ensure appropriate supplier controls
• Develop recommendation to ensure compliance to 21 CFR 820 and ISO 13485
• Communicate with suppliers to obtain necessary records where appropriate (FAI, Control Plans, CoC, etc.)
• Confirm that processes affecting CTQs are in control
Successful candidates for the Quality Assurance (QA) Engineer position have high level knowledge of the 21 CFR 820, ISO 13485 and ISO 14971. Someone with a questioning attitude, able to prioritize and execute tasks in a dynamic environment will excel in this role.
Additional requirements include:
• Bachelor’s Degree in Mechanical or Electrical Engineering
• Expert working knowledge of standards and regulations applicable to supplier controls affecting a medical device
• Requires strong working knowledge of quality assurance principles and practices, industry and international safety standards
• Minimum 5-years’ experience in medical device or pharma environment
• Must possess excellent communication (verbal & written) skills
• Must practice analytical problem solving skills
• Working knowledge of various software packages including Microsoft (Excel, Word, Project, and SharePoint) and SAP applications is desirable.
• Knowledge of implementing testing frameworks
• Highly organized with efficient use of time
• Ability to facilitate collaboration with cross-functional groups development in a team environment