Sr. Quality Engineer (CAPA/NC)

Ledgent Technology; Redmond; Presencial; AUD 128.000 - 140.000; Jornada completa

Descripción de la vacante

Ledgent Technology seeks a Sr. QA Engineer to join a client site in Redmond, WA. You will own CAPA/NC records, coordinate with Operations and suppliers, and drive quality improvements across manufacturing processes.

Responsibilities include root-cause analysis, problem-solving, and validation activities, with exposure to medical device quality systems and TrackWise/MASTERCONTROL usage. Location is on-site with some flexibility after training.

Formación

• Engineering or science degree (BS).
• Experience with CAPA/NC management in a regulated environment.
• Knowledge of TrackWise, MasterControl, and SAP preferred.
• Strong root cause analysis and problem-solving skills.
• Ability to collaborate with cross-functional teams.

Responsabilidades

• Investigate non-conformances, CAPAs, and quality issues.
• Perform root cause analysis and lead problem-solving huddles.
• Collaborate with Operations and suppliers to address quality issues.
• Support manufacturing transfers and supplier quality activities.
• Maintain KPIs and monitor trends to drive improvements.

Conocimientos

CAPA management

NC tracking

Root cause analysis

Quality systems

Cross-functional collaboration

Educación

BS engineering

Herramientas

TrackWise

MasterControl

SAP

Descripción del empleo

We are seeking a Sr. QA Engineer (CAPA's and NC's, medial equipment manufacturing) to work on a team at our client site in Redmond, WA. Candidates requiring relocation will be considered, but please note that expenses are not covered.

Pay Rate: $65.00 - $70.81 on a W2 with Roth Staffing (Ledgent Tech and Ultimate Staffing are divisions of Roth).

Start/End Dates: 11/23/2026 - 11/22/2027

Key Areas of Responsibility

• Work closely with Operations and th e 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.

Work Schedule & On‑Site Expectations

• First shift
• On site 4 days/week, 1 remote day (remote day will come later following full training)
• 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

• 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

• Manufacturing operators (on the line and at their desk)
• Regulatory
• Compliance
• 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
• Documentation reviews

The team has a broad scope of influence across quality systems and operations.

Preferred (Not Required) Background

• Medical device experience
• Experience in a regulated industry

Required Background

• Engineering or science degree (BS)

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

Desired Skills and Experience

This would be a universal player conducting Quality Engineering based work. Their day to day will likely vary, depending on what is going on in the manufacturing space and business needs. They will own NCs and potentially CAPAs, needing to bring in cross functional teams, driving with urgency to resolve the issue. They will contain nonconforming product and work with the Operations team when a line down situation occurs, which is a fast-paced environment. They will also work with Operations to ensure quality performances of products and processes. They will own PPAPs, for supplier changes, which can be an urgent change or ones that are less urgent. They may also be brought into process improvements/validation reviews for internal efforts.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.