Sr. Quality Assurance Engineer (Medical Device)
iMPact Business Group · Redmond, WA
Posted Sep 9, 2026
Job Description
Our client, a Global Medical Device Manufacturer, has an immediate opening for a Quality Assurance Engineer for an 18-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.
40 hour work week – Shift 7:30am to 5/6:00pm (Monday – Thursday and flex on Fridays if needed). Potentially, 1 remote day per week.
Requirements
- Work closely with Operations and the business functions to ensure quality performance of product and processes.
- Non-Conformances
o Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
o Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.
o Support execution and analysis of manufacturing related complaint investigations and product field actions.
o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
- Supplier Activities
o Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval
o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
o Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
- Process Improvements/Validation
o Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.
o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
o Participate in and potentially lead the creation and/or review of new or modified procedures.
o Support the development and review of process and equipment validation/qualification and MSA of internal processes.
o Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
Qualifications
- Bachelor's Degree in science/technical field. Minimum of 3 years of experience. Operations/Manufacturing Experience.
- CAPA/NCs Experience.
- SAP/ERP Systems experience. TrackWise a plus!
- Strong quality background with CQE and/or LSSGB or LSSBB certification
- Previous medical device industry experience desired with understanding of US and International Medical Device Regulations, familiarity with ISO 13485, GDP, GMP as well as experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) and in working in compliance risk situations.
- Strong knowledge of and experience with key Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics, DMAIC, DFSS).
Skills:
Analysis Skills, Certified Quality Engineer (CQE), Change Management, Change Order Management, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Design for Six Sigma (DFSS), Detail Oriented, Distribution Services, ERP (Enterprise Resource Planning), Equipment Validation, FDA Requirements, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Manufacturing, Manufacturing Analysis, Manufacturing/Industrial Processes, Medical Equipment, Performance Metrics, Problem Solving Skills, Procedure Development, Process Improvement, Process Validation, Production Part Approval Process (PPAP), Quality Assurance, Regulations, Risk, Risk Management, SAP ECC (fka SAP R/3 and SAP ERP), Six Sigma DMAIC, Statistics, Team Player, Time Management, Trend Analysis, Vendor/Supplier Management, Vendor/Supplier Selection
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iMPact Business Group, Inc.
Working with iMPact
Here at iMPact we have helped connect candidates to opportunities available in Information Technology, Accounting/Finance, Engineering, and Business Process/Administration. We have full-time, part-time and contract positions available in Michigan, Florida as well as nationwide.
Our headquarters is located in Grand Rapids, MI and we also have an office in Tampa, FL. When you’re working with us, one of our experienced recruiters will connect you with matching opportunities and they will be there every step of the way to help you through the application, interviewing and onboarding process to ensure success.
To connect with one of our recruiters, submit your application for one of our open positions, or visit our website
www.impactbusinessgroup.com to submit your resume for general consideration. We look forward to hearing from you!
Company Size:
100 to 499 employees
Industry:
Staffing/Employment Agencies
undefined:
2004
Website:
https://impactbusinessgroup.com
40 hour work week – Shift 7:30am to 5/6:00pm (Monday – Thursday and flex on Fridays if needed). Potentially, 1 remote day per week.
Requirements
- Work closely with Operations and the business functions to ensure quality performance of product and processes.
- Non-Conformances
o Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
o Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.
o Support execution and analysis of manufacturing related complaint investigations and product field actions.
o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
- Supplier Activities
o Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval
o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
o Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
- Process Improvements/Validation
o Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.
o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
o Participate in and potentially lead the creation and/or review of new or modified procedures.
o Support the development and review of process and equipment validation/qualification and MSA of internal processes.
o Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
Qualifications
- Bachelor's Degree in science/technical field. Minimum of 3 years of experience. Operations/Manufacturing Experience.
- CAPA/NCs Experience.
- SAP/ERP Systems experience. TrackWise a plus!
- Strong quality background with CQE and/or LSSGB or LSSBB certification
- Previous medical device industry experience desired with understanding of US and International Medical Device Regulations, familiarity with ISO 13485, GDP, GMP as well as experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) and in working in compliance risk situations.
- Strong knowledge of and experience with key Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics, DMAIC, DFSS).
Skills:
Analysis Skills, Certified Quality Engineer (CQE), Change Management, Change Order Management, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Design for Six Sigma (DFSS), Detail Oriented, Distribution Services, ERP (Enterprise Resource Planning), Equipment Validation, FDA Requirements, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Manufacturing, Manufacturing Analysis, Manufacturing/Industrial Processes, Medical Equipment, Performance Metrics, Problem Solving Skills, Procedure Development, Process Improvement, Process Validation, Production Part Approval Process (PPAP), Quality Assurance, Regulations, Risk, Risk Management, SAP ECC (fka SAP R/3 and SAP ERP), Six Sigma DMAIC, Statistics, Team Player, Time Management, Trend Analysis, Vendor/Supplier Management, Vendor/Supplier Selection
undefined:
iMPact Business Group, Inc.
Working with iMPact
Here at iMPact we have helped connect candidates to opportunities available in Information Technology, Accounting/Finance, Engineering, and Business Process/Administration. We have full-time, part-time and contract positions available in Michigan, Florida as well as nationwide.
Our headquarters is located in Grand Rapids, MI and we also have an office in Tampa, FL. When you’re working with us, one of our experienced recruiters will connect you with matching opportunities and they will be there every step of the way to help you through the application, interviewing and onboarding process to ensure success.
To connect with one of our recruiters, submit your application for one of our open positions, or visit our website
www.impactbusinessgroup.com to submit your resume for general consideration. We look forward to hearing from you!
Company Size:
100 to 499 employees
Industry:
Staffing/Employment Agencies
undefined:
2004
Website:
https://impactbusinessgroup.com
Additional Details
- City
- Redmond
- State
- Washington
- Country
- US
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