Quality Engineer

Job Title: Supplier and Manufacturing Quality Engineer Job Description
This role focuses on ensuring the quality performance of products and processes by working closely with Operations, Manufacturing, and cross-functional business teams. The Quality Engineer manages non-conformances and CAPA activities, supports supplier quality and change management, and drives continuous improvement in a live production environment. The position requires strong problem-solving skills, the ability to lead investigations and discussions, and the capability to support both supplier and internal manufacturing quality in a regulated environment.
Responsibilities
- Work closely with Operations and business functions to ensure consistent quality performance of products and processes.
- Collaborate with internal cross-functional teams and suppliers to address top quality issues and drive effective resolutions.
- Own internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action (CAPA) records, ensuring timely processing and closure within the electronic quality management system (e.g., TrackWise).
- Support the execution and analysis of manufacturing-related complaint investigations and product field actions, ensuring appropriate corrective and preventive actions.
- Investigate and disposition internal non-conforming product within Material Review Board (MRB) processes, issuing NCs as appropriate.
- Communicate and collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) when required.
- Execute and manage Supplier Initiated Change Requests (SICRs), coordinating with cross-functional teams for assessment, impact analysis, and approval.
- Support manufacturing transfers to and from other plants or facilities by executing appropriate quality activities and ensuring compliance with quality requirements.
- Collaborate with stakeholders to identify and execute opportunities for supplier part certification and improved incoming quality.
- Engage in the development and improvement of 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, when needed, lead the creation and review of new or revised procedures, work instructions, and quality documentation.
- Support the development and review of process and equipment validation and qualification activities, including measurement system analysis (MSA) of internal processes.
- Maintain key performance indicators (KPIs) for monitoring process and product quality, perform data analysis, interpret trends, and initiate appropriate actions based on findings.
- Provide quality support for live production issues, quickly assessing problems, implementing containment, and helping keep operations moving.
- Work frequently with manufacturing operators on the line and at their desks, as well as with Engineering, Regulatory, Compliance, and supplier teams.
- Lead or actively contribute to root cause analysis activities, ensuring robust corrective and preventive actions are defined, implemented, and verified for effectiveness.
- Prepare and manage change orders and associated documentation within the quality system, ensuring compliance with internal and regulatory requirements.
- Communicate clearly with stakeholders regarding quality issues, investigation status, and resolution plans, ensuring alignment and timely decision-making.
- Perform other related duties as assigned to support overall quality, compliance, and operational objectives.
Essential Skills
- Proven experience in both supplier quality and product/manufacturing quality, with roughly balanced exposure to each area.
- Strong root cause analysis experience, including leading investigations and driving effective corrective and preventive actions.
- Hands-on experience with Non-Conformances (NC) and CAPA processes, including documentation, follow-up, and closure.
- Experience handling supplier issues and supplier change management, including Supplier Initiated Change Requests (SICRs) and SCARs.
- Experience handling internal manufacturing issues and changes, supporting live production and process improvements.
- Validation experience for both process and equipment, including participation in or support of qualification activities.
- Experience working with change orders and quality system documentation within a formal quality management system.
- Ability to support live production issues, pivot quickly, and keep operations moving in a dynamic environment.
- Comfort working in high-pressure, time-sensitive situations with frequent changes and a fluid day-to-day workload.
- Ability to work independently and collaboratively across teams, taking ownership and driving actions to completion.
- Experience interacting with Manufacturing, Engineering, Quality, Regulatory, Compliance, and supplier stakeholders.
- Strong problem-solving skills with a structured and analytical approach to quality issues.
- Clear and confident communication skills, especially when explaining issues, investigation outcomes, and resolution plans.
- Ability to lead conversations, influence stakeholders, and drive resolution in cross-functional settings.
- Background in a regulated industry, such as medical devices or similar highly regulated sectors.
- Degree in engineering or a science-related discipline, or equivalent relevant education and experience.
Additional Skills & Qualifications
- Experience with Production Part Approval Process (PPAP) for supplier changes and new or modified components.
- Knowledge of Failure Mode and Effects Analysis (FMEA), including design and process FMEA, and related risk management tools.
- Familiarity with control plans and process flow documentation for manufacturing processes.
- Experience using TrackWise or similar electronic quality management systems for NC, CAPA, and change management.
- Experience with MasterControl or comparable document and quality management platforms.
- Working knowledge of SAP or similar enterprise resource planning (ERP) systems.
- Experience in a medical device environment or other highly regulated manufacturing setting.
- Hands-on experience on a manufacturing floor, including interaction with operators and understanding of production workflows.
- Naturally curious and investigative mindset, with a strong desire to understand root causes and systemic issues.
- Comfort leading discussions with diverse stakeholders, including suppliers and internal teams, to align on quality solutions.
- Ability to explain complex technical and quality topics in a clear and concise manner to different audiences.
- Demonstrated ownership mentality, with a focus on driving action, closing gaps, and sustaining improvements.
Work Environment
The role is primarily on site, with four days per week spent at the facility and one day available for remote work. Typical working hours start between 7:00 a.m. and 8:00 a.m., totaling approximately 40 hours per week. The position operates in a live production environment where priorities can shift quickly, requiring the ability to pivot between tasks and respond to real-time manufacturing issues. You will interact frequently with manufacturing operators on the production line and at their desks, as well as with Engineering, Regulatory, Compliance, and supplier teams. The environment is dynamic and fast-paced, with constant change and time-sensitive situations that demand strong organization, clear communication, and a calm, solution-focused approach. Standard professional attire appropriate for a manufacturing and office setting is expected, along with adherence to any site-specific safety and cleanliness requirements.
Job Type & Location
This is a Contract position based out of Redmond, WA.
Pay and Benefits
The pay range for this position is $64.52 - $70.81/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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)
Workplace Type
This is a fully onsite position in Redmond,WA.
Application Deadline
This position is anticipated to close on Oct 19, 2026. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without
regard to race, sex, age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any characteristic protected
by law.

If you would like to request a reasonable accommodation, such as the modification or
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San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
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