Senior Engineer, Quality Assurance Engineering

Description

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.

Skills

Root Cause Analysis, Non-Conformances, CAPA

Top Skills Details

Root Cause Analysis,Non-Conformances,CAPA

Additional Skills & Qualifications

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) Example of a successful prior hire: • Background in bioscience/lab work • No direct manufacturing experience initially • Strong technical thinking, stakeholder management, and execution speed • Successfully translated lab skills into manufacturing quality work 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 Can you give us an overview of the project this resource would be working on and what the day-to-day activities would look like? This isn’t an ask to support a project.

Experience Level

Expert Level

This is a Contract position based out of Redmond, WA.

The pay range for this position is $48.00 - $54.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Redmond,WA.

This position is anticipated to close on Apr 24, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $48 - $54