Senior Medical Device QA Engineer (Contract)

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

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.