Job Description
18-Month+ Contract | 40 Hours/Week | Monday–Thursday, 7:30 AM–5:00/6:00 PM | Friday Flex as Needed | Potential 1 Remote Day/Week
Our client, a global leader in the medical device industry, has an immediate opening for a Quality Assurance Engineer for an 18-month+ contract. This opportunity is ideal for a quality professional with strong manufacturing experience who can drive non-conformance investigations, CAPA activities, supplier quality initiatives, and process improvements within a highly regulated environment.
Key Focus
- Non-Conformances (NC) and CAPA
- Supplier Quality and Corrective Actions
- Manufacturing and Process Quality
- PPAP and Change Management
- Process and Equipment Validation
- Medical Device Quality Systems
What You'll Do
- Partner with Operations and cross-functional teams to ensure product and process quality performance.
- Own internal and supplier-driven Non-Conformances (NCs) and CAPAs, including timely processing and closure within TrackWise.
- Investigate and disposition non-conforming product through the Material Review Board (MRB) process.
- Support manufacturing-related complaint investigations and product field actions.
- Collaborate with suppliers to resolve quality issues and initiate Supplier Corrective Action Requests (SCARs) when required.
- Manage Supplier Initiated Change Requests (SICRs) and coordinate cross-functional assessment and approval.
- Support manufacturing transfers between plants and facilities.
- Identify and execute opportunities for supplier part certification.
- Support improvements to internal manufacturing and distribution processes.
- Assess internal and supplier-proposed changes, including Production Part Approval Process (PPAP) activities.
- Participate in the creation and review of new or modified quality procedures.
- Support process and equipment validation, qualification, and Measurement System Analysis (MSA).
- Maintain quality KPIs, analyze trends, and initiate appropriate corrective actions.
What We're Looking For
- Bachelor's degree in a science or technical field.
- Minimum 3 years of quality experience, including operations or manufacturing experience.
- Hands-on CAPA and Non-Conformance experience.
- Experience with SAP or other ERP systems.
- TrackWise experience is highly preferred.
- Strong understanding of quality concepts including Risk Management, CAPA, Audits, Statistics, DMAIC, and DFSS.
- CQE, Lean Six Sigma Green Belt (LSSGB), or Lean Six Sigma Black Belt (LSSBB) certification preferred.
- Medical device industry experience preferred.
- Familiarity with ISO 13485, GDP, GMP, and U.S. and international medical device regulations preferred.
- Experience working with regulatory agencies such as the FDA, MoH, or TÜV is a plus.
Numbers & Facts
| Location | Redmond, WA |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 2004 |
| Website | https://impactbusinessgroup.com |
About Company
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!
Skills
- Certified Quality Engineer (CQE)unmatched
- Change Managementunmatched
- Change Order Managementunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Design for Six Sigma (DFSS)unmatched
- Distribution Servicesunmatched
- ERP (Enterprise Resource Planning)unmatched
- Equipment Validationunmatched
- FDA (Food and Drug Administration)unmatched
- Functional Analysisunmatched
- GMP (Good Manufacturing Practices)unmatched
- Healthcare Qualityunmatched
- ISO (International Organization for Standardization)unmatched
- Lean Six Sigmaunmatched
- Manufacturingunmatched
- Manufacturing/Industrial Processesunmatched
- Medical Equipmentunmatched
- Performance Metricsunmatched
- Problem Solving Skillsunmatched
- Procedure Developmentunmatched
- Process Improvementunmatched
- Process Qualityunmatched
- Process Validationunmatched
- Production Part Approval Process (PPAP)unmatched
- Quality Assuranceunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Risk Managementunmatched
- SAP ECC (fka SAP R/3 and SAP ERP)unmatched
- Six Sigma Black Beltunmatched
- Six Sigma DMAICunmatched
- Six Sigma Green Beltunmatched
- Statisticsunmatched
- Systems Analysisunmatched
- Time Managementunmatched
- Trend Analysisunmatched
- Vendor/Supplier Evaluationunmatched
- Vendor/Supplier Managementunmatched
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