Senior Quality Assurance Engineer

GForce Life Sciences; Redmond (WA); On-site; USD 100,000 - 150,000; Full time

Job summary

GForce Life Sciences in Redmond, WA is seeking a Senior Quality Assurance Engineer to support product and process quality in a manufacturing setting. This 18-month contract focuses on non-conformances, CAPA, supplier quality, and data-driven improvements.

The role collaborates with Operations and suppliers to investigate quality issues, drive corrective actions, and ensure robust processes and PPAP/MSA activities. Onsite four days per week; W2 eligibility.

Qualifications

• Bachelor's degree in Engineering or equivalent.
• 3+ years of Quality Engineering experience.
• Experience with non-conformances, CAPA and root cause investigations.
• Experience working with suppliers to resolve quality issues.
• Familiarity with TrackWise or similar EQA systems.

Responsibilities

• Own NCs and CAPAs and manage closure in TrackWise.
• Collaborate with operations and suppliers to address quality issues.
• Support manufacturing transfers and process validation activities.
• Lead or support PPAP activities related to supplier changes.
• Develop and maintain quality KPIs and data analysis.
• Review and update quality procedures as needed.
• Assist in CAPA investigations and escalation as required.
• Support supplier quality improvements and SCARs.

Skills

Quality engineering

Non-conformances

CAPA

Root cause analysis

Supplier quality

TrackWise

PPAP

MSA

Data analysis

Communication

Education

Bachelor's degree in Engineering

Tools

TrackWise

MSA tools

PPAP

QMS experience

Job description

Position Summary

Our client, a leading medical device company, is seeking a Senior Quality Assurance Engineer to support product and process quality within a manufacturing environment. This role will focus on non-conformances, CAPA, supplier quality, corrective actions, process improvements, validation, and quality data analysis. The Quality Engineer will work closely with Operations, suppliers, and cross-functional teams to investigate quality issues, implement corrective actions, and improve manufacturing processes.

18-Month Contract

Onsite 4 Days/Week in Redmond, WA

Must Be Able to Work on a W2

Position Summary

Our client, a leading medical device company, is seeking a Senior Quality Assurance Engineer to support product and process quality within a manufacturing environment. This role will focus on non-conformances, CAPA, supplier quality, corrective actions, process improvements, validation, and quality data analysis. The Quality Engineer will work closely with Operations, suppliers, and cross-functional teams to investigate quality issues, implement corrective actions, and improve manufacturing processes.

Responsibilities

• Work closely with Operations and business functions to ensure quality performance of products and processes.
• Own internal and supplier-driven Non-Conformances (NCs) and CAPAs, managing timely processing and closure within TrackWise.
• Collaborate with internal cross-functional and supplier teams to address top quality issues.
• Support manufacturing-related complaint investigations and product field actions.
• Investigate and disposition internal non-conforming product through MRB and issue NCs as appropriate.
• Communicate and collaborate with suppliers regarding non-conformances and **escalate** Supplier Corrective Action Requests (SCARs) as needed.
• Manage Supplier Initiated Change Requests (SICRs), coordinating with cross-functional teams for assessment and approval.
• Support manufacturing transfers between plants and facilities by executing appropriate quality activities.
• Identify and support opportunities for supplier part certification and supplier quality improvement.
• Support the development and improvement of internal manufacturing and distribution processes.
• Evaluate internal and supplier-proposed changes, including PPAP activities related to supplier changes.
• Participate in or lead the creation and review of new or modified procedures.
• Support process and equipment validation/qualification and Measurement System Analysis (MSA) activities.
• Maintain quality KPIs, analyze data, and identify trends in product and process quality.
• Recommend and implement appropriate corrective and preventive actions based on quality trends and data.
• Perform other related duties as assigned.

Requirements And Qualifications

• Bachelor's degree in Engineering or equivalent technical discipline.
• 3+ years of Quality Engineering experience.
• Experience with Non-Conformances, CAPA, corrective actions, and root cause investigations.
• Experience working with suppliers to resolve quality issues.
• Experience with SCARs and supplier quality activities preferred.
• Experience with TrackWise or a similar electronic quality management system preferred.
• Knowledge of PPAP, change management, process validation/qualification, and MSA.
• Strong analytical skills with the ability to identify trends and make data-driven recommendations.
• Strong attention to detail and sound judgment when evaluating quality issues.
• Ability to work independently with minimal supervision.
• Strong communication and cross-functional collaboration skills.