Senior Engineer, Quality Assurance Engineering

Responsibilities

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:

Manufacturing operators (on the line and at their desk)

Engineering

Regulatory

Compliance

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.

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Contact:

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Job Facts: Contract Independent | On-site | USD $60.00 - 70.00 per hour

Skills: Quality Assurance, Insurance, Trackwise, MRB, Corrective And Preventive Action, Management, Collaboration, Distribution, Change Management, PPAP, KPI, Manufacturing Operations, Conflict Resolution, Problem Solving, Process Improvement, Root Cause Analysis, Communication, Regulatory Compliance, Manufacturing, Documentation, Quality Management, Privacy, Marketing

Reference: Dice Id: cxjudgpa | Position Id: 1160525

Project details

Redmond, WA Salary: $60.00 USD Hourly - $70.00 USD Hourly Description: Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 12 month + contract.

Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.

Key Areas of Responsibility:

Work closely with Operations and the business functions to ensure quality performance of product and processes.

Non-Conformances

Collaborate with Internal cross-functional and Supplier teams to address top quality issues.

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.

Support execution and analysis of manufacturing related complaint investigations and product field actions.

Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.

Supplier Activities

Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.

Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval

Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.

Process Improvements/Validation

Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.

Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.

Participate in and potentially lead the creation and/or review of new or modified procedures.

Support the development and review of process and equipment validation/qualification and MSA of internal processes.

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.

Role Overview The Quality Engineer supports both: Manufacturing operations, and Suppliers

• Start: flexible
• Remote: onsite
• Location: Redmond, WA, US, US
• Rate: 60-70 EUR/h