Overview
Sr. Eng, Quality Assurance Jobs in Redmond, WA at IntePros
Title: Sr. Eng, Quality Assurance
Company: IntePros
Location: Redmond, WA
Overview
We are partnering with one of the industry’s leading medical device manufacturers to find a highly skilled Senior Quality Assurance Engineer. This role is integral to ensuring the quality performance of products and processes while collaborating closely with internal teams, suppliers, and cross-functional stakeholders. The ideal candidate will bring expertise in quality systems, supplier management, process improvements, and regulatory compliance within the medical device industry.
Key Areas of Responsibility:1. Quality Performance & Non-Conformances
Collaborate with internal teams and suppliers to address top quality issues effectively.
Own and manage Non-Conformances (NC) and Corrective Action Preventative Action (CAPA) records, ensuring timely processing and closure within the electronic management system (Trackwise).
Support manufacturing-related complaint investigations and product field actions.
Investigate and disposition internal non-conforming products within the Material Review Board (MRB) while issuing NCs as needed.
2. Supplier Quality Activities
Act as the liaison with suppliers regarding non-conformances and escalate Supplier Corrective Action Requests (SCAR) as required.
Manage Supplier-Initiated Change Requests (SICRs), coordinating cross-functional assessments and approvals.
Support manufacturing transfers between facilities, executing necessary quality activities.
Partner with stakeholders to identify and implement supplier part certification opportunities.
3. Process Improvements & Validation
Drive the development and improvement of internal manufacturing and distribution processes for existing products.
Conduct critical assessments and qualifications for internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP).
Participate in or lead the creation and review of new or revised procedures.
Support process and equipment validation/qualification, as well as Measurement System Analysis (MSA) for internal processes.
Monitor Key Performance Indicators (KPIs) to track process and product quality, analyze trends, and take appropriate actions.
4. Additional Responsibilities
Perform other related duties as assigned to ensure overall quality and regulatory compliance.
Qualifications:
Bachelor’s degree in Engineering, Quality Management, or a related field (or equivalent experience).
Proven experience in quality assurance within the medical device industry.
Strong knowledge of quality systems, CAPA, NC management, and supplier quality activities.
Familiarity with electronic quality management systems (Trackwise preferred).
Experience with process improvements, validation activities, and PPAP.
Excellent communication and collaboration skills for cross-functional and supplier interactions.
Detail-oriented with a strong ability to analyze and interpret data.
Why Join?
This role provides the opportunity to work with a leader in the medical device space, contributing to life-changing products and innovative processes. Be part of a team that values collaboration, continuous improvement, and a commitment to excellence.
Apply Today!
If you’re ready to take the next step in your quality assurance career, apply now to join a dynamic and innovative organization.
