Senior Quality Assurance Engineer

IntePros; Redmond (WA); On-site; USD 90,000 - 130,000; Full time

Job summary

IntePros is seeking a Senior Quality Assurance Engineer to join a leading client in the medical device/manufacturing industry. This role focuses on quality improvement, CAPA/NC leadership, and cross-functional collaboration with Operations, Engineering, and suppliers.

The ideal candidate has experience in regulated manufacturing, CAPA/NC processes, and quality data analysis to drive product and process enhancements.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 2+ years of Quality or Manufacturing Engineering experience.
• Experience in a regulated manufacturing environment.
• Medical device experience strongly preferred.
• Experience with CAPA, NCs, supplier quality, and corrective actions.
• TrackWise or another eQMS experience preferred.

Responsibilities

• Lead Non-Conformances (NCs) and CAPAs through investigation and closure.
• Investigate manufacturing quality issues and support MRB activities.
• Work with suppliers on SCARs, SICRs, and quality improvements.
• Support PPAP, validation/qualification, MSA, and change management.
• Analyze quality data and KPIs to identify improvement opportunities.
• Help develop and improve quality and manufacturing processes.

Skills

Non-conformance handling

CAPA management

Supplier quality

Quality data analysis

Process improvement

Education

Bachelor’s degree in Engineering

Tools

TrackWise

Job description

Redmond, WA (4 days/wk onsite)

IntePros is seeking a Senior Quality Assurance Engineer to join a leading client in the medical device/manufacturing industry.

This is a great opportunity for a quality-focused engineer who enjoys working cross-functionally, solving manufacturing issues, and driving continuous improvement. You’ll partner with Operations, Engineering, and suppliers to improve product and process quality.

Responsibilities

• Lead Non-Conformances (NCs) and CAPAs through investigation and closure
• Investigate manufacturing quality issues and support MRB activities
• Work with suppliers on SCARs, SICRs, and quality improvements
• Support PPAP, validation/qualification, MSA, and change management
• Analyze quality data and KPIs to identify improvement opportunities
• Help develop and improve quality and manufacturing processes

Required Experience

• Bachelor’s degree in Engineering or related field
• 2+ years of Quality or Manufacturing Engineering experience
• Experience in a regulated manufacturing environment
• Medical device experience strongly preferred
• Experience with CAPA, NCs, supplier quality, and corrective actions
• TrackWise or another eQMS experience preferred