Senior Quality Assurance Engineering

The Matlen Silver Group, Inc.; Redmond (WA); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health, Vision, and Dental Insurance

401(k) plan (employee contributions)

Job summary

The Matlen Silver Group, Inc. is seeking a Senior Quality Assurance Engineer in Redmond to support medical device manufacturing quality systems and supplier quality activities. You will drive investigations, CAPAs, and continuous improvement across operations and suppliers.

This on-site role blends collaboration with Regulatory, Compliance, and Operations, and offers a path to process validation, PPAP activities, and cross-functional leadership within a fast-paced environment.

Qualifications

• Strong root cause analysis and problem-solving skills.
• Experience managing quality investigations and corrective actions.
• Ability to lead cross-functional discussions and influence stakeholders.
• Strong communication skills and ability to manage multiple priorities.
• Comfortable working in a fast-paced manufacturing environment.

Responsibilities

• Lead investigations of nonconformances (NCs), CAPAs, and quality issues.
• Perform root cause analysis and drive corrective actions to closure.
• Support complaint investigations, product field actions, and MRB activities.
• Partner with Operations to resolve manufacturing issues, including line-down situations.
• Monitor quality metrics and identify opportunities for improvement.
• Collaborate with suppliers on quality issues and corrective actions.
• Manage Supplier Corrective Action Requests (SCARs) and Supplier Initiated Change Requests (SICRs).
• Support supplier changes, manufacturing transfers, and PPAP activities.
• Support process, equipment, and validation activities.
• Review validation protocols, reports, change orders, and quality documentation.
• Participate in procedure development and continuous improvement efforts.

Skills

Root cause analysis

Quality investigations

CAPA management

Cross-functional collaboration

Stakeholder influence

Communication skills

Fast-paced manufacturing

Education

Bachelor's degree in Engineering, Science, or related field

Tools

TrackWise

MasterControl

SAP

Job description

Senior Quality Assurance Engineering (BH-109790)

Location Redmond, United States Sector Medical & Nursing Salary Competitive

Position Title:Senior Engineer - Quality Assurance Engineering

Location: Redmond Washington 98052(On site 4 Day, 1 remote day)

Duration: 12-24 Months (Possible Extension/Conversion)/ No C2C

***Due to client requirements this role is only open to USC OR GC candidates***

Position Overview

Client is seeking a Quality Engineer to support manufacturing operations and supplier quality activities in a fast-paced environment. This role partners closely with Operations, Engineering, Regulatory, Compliance, and Suppliers to ensure product and process quality while driving investigations, corrective actions, and continuous improvement initiatives.

Key Responsibilities

Quality & Manufacturing Support

• Lead investigations of nonconformances (NCs), CAPAs, and quality issues.
• Perform root cause analysis and drive corrective actions to closure.
• Support complaint investigations, product field actions, and MRB activities.
• Partner with Operations to resolve manufacturing issues, including line-down situations.
• Monitor quality metrics and identify opportunities for improvement.

Supplier Quality

• Collaborate with suppliers on quality issues and corrective actions.
• Manage Supplier Corrective Action Requests (SCARs) and Supplier Initiated Change Requests (SICRs).
• Support supplier changes, manufacturing transfers, and PPAP activities.

Process Improvement & Validation

• Support process, equipment, and validation activities.
• Review validation protocols, reports, change orders, and quality documentation.
• Participate in procedure development and continuous improvement efforts.

Qualifications

Required

• Strong root cause analysis and problem-solving skills.
• Experience managing quality investigations and corrective actions.
• Ability to lead cross-functional discussions and influence stakeholders.
• Strong communication skills and ability to manage multiple priorities.
• Comfortable working in a fast-paced manufacturing environment.

Preferred

• Bachelor's degree in Engineering, Science, or a related field.
• Experience in manufacturing, quality engineering, or regulated industries.
• Medical device experience preferred.
• Knowledge of PPAP, DFMEA/PFMEA, Control Plans, and validation activities.

Systems & Tools

• TrackWise
• MasterControl
• SAP (preferred but not required)

Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: [e-mail] // 908-393-8600

At The Matlen Silver Group, Inc., W2 employees are eligible for the following benefits:

• Health, vision, and dental insurance (single and family coverage)
• 401(k) plan (employee contributions only)