Sr. Quality Assurance Engineer (Medical Device)

Impact Business Group; Redmond (WA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Impact Business Group seeks aQuality Assurance Engineer for a 12-month+ contract, located in Redmond, WA. The role focuses on non-conformances, CAPA, supplier quality, PPAP, and process validation within a regulated medical device framework.

You will collaborate with operations and suppliers to drive quality improvements, manage NCs and CAPAs, and support transfers and field actions as needed.

Qualifications

• Bachelor's degree in science/technical field.
• Minimum 3 years of quality experience including operations/manufacturing.
• Hands-on CAPA and Non-Conformance experience.
• Experience with SAP or other ERP systems.
• TrackWise experience preferred.
• Knowledge of quality concepts including Risk Management, CAPA, Audits, Statistics, DMAIC, and DFSS.
• CQE, LSSGB, or LSSBB certification preferred.
• Medical device industry experience preferred.
• Familiarity with ISO 13485, GDP, GMP and U.S./international medical device regulations preferred.
• Experience with regulatory agencies such as FDA, MoH, or TÜV is a plus.

Responsibilities

• Partner with Operations and cross-functional teams to ensure product and process quality.
• Own NCs and CAPAs, including timely processing and closure within TrackWise.
• Investigate and disposition non-conforming product through MRB process.
• Support manufacturing-related complaint investigations and product field actions.
• Collaborate with suppliers to resolve quality issues and initiate SCARs when required.
• Manage SICRs and coordinate cross-functional assessment and approval.
• Support manufacturing transfers between plants and facilities.
• Identify opportunities for supplier part certification.
• Support improvements to internal manufacturing and distribution processes.
• Assess internal and supplier-proposed changes, including PPAP activities.
• Participate in creation/review of new or modified quality procedures.
• Support process and equipment validation, qualification, and MSA.
• Maintain quality KPIs, analyze trends, and initiate corrective actions.

Skills

CAPA

Non-Conformance

Quality Systems

Root Cause Analysis

Process Improvement

Education

Bachelor's degree in science or engineering

Tools

SAP

TrackWise

ERP systems

Job description

12-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 12-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 T?V is a plus.