Location: Redmond, WA
Salary: $45.00 USD Hourly - $57.00 USD Hourly
Description: Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 12 month + contract.
Key Areas of Responsibility:
Work closely with Operations and the business functions to ensure quality performance of product and processes.
Non-Conformances
o Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
o Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.
o Support execution and analysis of manufacturing related complaint investigations and product field actions.
o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
Supplier Activities
o Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval
o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
o Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
Process Improvements/Validation
o Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.
o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
o Participate in and potentially lead the creation and/or review of new or modified procedures.
o Support the development and review of process and equipment validation/qualification and MSA of internal processes.
o Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
Perform other related duties as assigned.
Work Schedule & On-Site Expectations
First shift
On site 4 days/week, 1 remote day
Typical hours: 7:30 AM-5/6 PM No rigid schedule; flexibility based on workflow
Role Overview
The Quality Engineer supports both:
Manufacturing operations, and
Suppliers Key responsibilities include:
Investigating nonconformances, CAPAs, and quality issues
Performing root cause analysis
Leading cross-functional problem-solving huddles
Driving process improvements (efficiency, throughput, new equipment) This is a fast-paced, high-pressure environment, where multiple quality issues can arise at once. The QE must be able to pivot quickly, provide direction, and help get production back up and running.
Key Skills & Traits Needed
Naturally curious and investigative
Strong root cause analysis experience
Comfortable leading discussions and influencing stakeholders
Able to work independently and collaboratively
Strong communication skills, especially when explaining resolution plans
Comfortable working in stressful, time-sensitive situations Manufacturing & Stakeholder Interaction
Frequent interaction with:
o Manufacturing operators (on the line and at their desk) o Engineering
o Regulatory
o Compliance
o Suppliers
Experience on a manufacturing floor is highly desirable (but not required)
Documentation & Validation Work. The QE will review and/or support:
Validation protocols and reports
Process and equipment validation
Label reviews
Change orders
Documentation reviews
The team has a broad scope of influence across quality systems and operations.
Preferred (Not Required) Background
Medical device experience (preferred, not required)
Experience in a regulated industry
Engineering or science degree (BS preferred)
Tools & Systems Used
TrackWise - nonconformances, CAPAs, complaints
MasterControl - document management
SAP - order management, holds, manufacturing systems (SAP experience helpful but trainable)
Quality Tools & Concepts They Like to See
PPAP (nice to have)
Validation experience
DFMEA / PFMEA
Control Plans
Process Flow Diagrams
Ability to define requirements and collect objective evidence
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Contact:
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Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: cxjudgpa
- Position Id: 1128183
- Posted 2 days ago
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