Quality Engineer

Actalent; Redmond; On-site; AUD 126,000 - 139,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

PTO / Leave

Job summary

Actalent in Redmond, WA is seeking a Quality Engineer to ensure product and process quality in a live manufacturing environment. The role involves managing NCs and CAPAs, supporting supplier quality, and driving changes and validations across the plant.

You will collaborate with operations, engineering, quality, and regulatory teams, lead problem solving, PPAP activities, and maintain quality system documentation using TrackWise, MasterControl, and SAP.

Qualifications

• Engineering or science degree or equivalent technical education.
• Experience in medical devices or regulated industry.
• Experience on production floor and cross-functional teams.

Responsibilities

• Work closely with Operations and other business functions to ensure the quality performance of products and processes.
• Collaborate with internal cross-functional teams and suppliers to address top quality issues and drive effective resolutions.
• Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventive 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 robust documentation and follow-up.
• Investigate internal non-conforming product within the MRB process and issue NCs as appropriate, including disposition of non-conforming materials.
• Communicate and collaborate with suppliers regarding non-conformances and elevate SCARs as requested.
• Execute and manage SICRs, engaging cross-functional teams for technical assessment, risk evaluation, and approval.
• Support manufacturing transfers to and from other plants or facilities by executing appropriate quality activities.
• Collaborate with stakeholders to identify and implement opportunities for supplier part certification to improve incoming quality and efficiency.
• Engage in the development and improvement of internal manufacturing and distribution processes for existing products, focusing on quality, robustness, and efficiency.
• Perform PPAP activities for supplier or internal changes; participate in review of procedures related to quality and supplier management.
• Support development and review of process and equipment validation and MSA activities; maintain documented quality systems.
• Maintain KPIs for process and product quality, perform data analysis, interpret trends, and implement corrective actions.

Skills

Root cause analysis

CAPA management

Supplier quality

Change management

Process validation

PPAP

MSA

Documentation control

Regulatory awareness

Education

Engineering or science degree

Tools

TrackWise

MasterControl

SAP

ERP systems

Job description

Job Title: Quality Engineer

This role focuses on ensuring the consistent quality performance of products and processes by working closely with Operations and cross-functional business partners. The Quality Engineer manages non-conformances and CAPA activities, supports supplier quality and change management, and drives process improvements and validations in a live production environment. The position requires a balance of supplier quality and product/manufacturing quality experience, strong root cause analysis skills, and the ability to operate effectively in a fast-paced, highly regulated setting.

Responsibilities

• Work closely with Operations and other business functions to ensure the quality performance of products and processes.
• Collaborate with internal cross-functional teams and suppliers to address top quality issues and drive effective resolutions.
• Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventive 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 robust documentation and follow-up.
• Investigate internal non-conforming product within the Material Review Board (MRB) process and issue NCs as appropriate, including disposition of non-conforming materials.
• Communicate and collaborate with suppliers regarding non-conformances and elevate Supplier Corrective Action Requests (SCAR) as requested.
• Execute and manage Supplier Initiated Change Requests (SICRs), engaging cross-functional teams for technical assessment, risk evaluation, and approval.
• Support manufacturing transfers to and from other plants or facilities by executing appropriate quality activities and ensuring compliance with applicable procedures.
• Collaborate with stakeholders to identify and implement opportunities for supplier part certification to improve incoming quality and efficiency.
• Engage in the development and improvement of internal manufacturing and distribution processes for existing products, focusing on quality, robustness, and efficiency.
• Perform critical assessments and qualifications of internal and supplier-proposed changes, including conducting or supporting Production Part Approval Process (PPAP) activities for supplier changes.
• Participate in and, when appropriate, lead the creation, revision, and review of new or modified procedures related to quality, manufacturing, and supplier management.
• Support the development and review of process and equipment validation and qualification activities, as well as Measurement System Analysis (MSA) for internal processes.
• Maintain key performance indicators (KPIs) for monitoring process and product quality, perform data analysis, interpret trends, and implement appropriate corrective or preventive actions.
• Support live production issues in real time, helping to keep operations moving while maintaining compliance and product quality.
• Lead or actively contribute to discussions with stakeholders to explain issues, proposed fixes, and resolution plans in a clear and structured manner.
• Work independently and as part of cross-functional teams, taking ownership of issues and driving actions to closure.
• Perform other related duties as assigned to support overall quality and operational objectives.

Essential Skills

• Balanced experience in both supplier quality and product/manufacturing quality, with approximately a 50/50 focus.
• Strong experience in root cause analysis, including structured problem-solving methods to identify, contain, and eliminate quality issues.
• Hands-on experience managing Non-Conformances (NC) and Corrective Action Preventive Action (CAPA) activities from initiation through closure.
• Demonstrated experience with validation activities for both processes and equipment in a production or regulated environment.
• Experience handling supplier quality issues and change management, including supplier-initiated changes and internal change orders.
• Experience managing internal manufacturing issues and changes, ensuring quality and compliance during process updates or transfers.
• Proficiency with documentation and quality system work, including authoring, reviewing, and maintaining controlled documents.
• Ability to support live production issues, pivot quickly, and keep operations moving while maintaining quality standards.
• Comfort working in a high-pressure, time-sensitive environment with frequent changes and shifting priorities.
• Ability to work independently as well as collaboratively across teams, taking ownership and driving actions to completion.
• Strong communication skills, with the ability to clearly explain issues, root causes, and resolution plans to diverse stakeholders.
• Comfort leading discussions and influencing stakeholders, including manufacturing, engineering, quality, regulatory, compliance, and suppliers.
• Naturally curious and investigative mindset, with a strong problem-solving orientation.
• Demonstrated ability to take ownership, drive action, and lead conversations to resolution.
• Experience working in or closely with manufacturing environments, particularly on or near the production floor.
• Background in medical devices or another highly regulated industry.
• Engineering or science degree or equivalent technical education.
• Experience collaborating with manufacturing, engineering, quality, regulatory, and compliance functions.

Additional Skills & Qualifications

• Experience with Production Part Approval Process (PPAP) for supplier or internal changes.
• Familiarity with quality tools and methods such as Failure Mode and Effects Analysis (FMEA), Process FMEA (PFMEA), and control plans.
• Knowledge of process flow mapping and understanding of how process changes impact quality and compliance.
• Experience using TrackWise or similar electronic quality management systems.
• Experience with MasterControl or similar document and quality management systems.
• Experience with SAP or comparable enterprise resource planning (ERP) systems.
• Prior experience in a medical device or other regulated industry, with understanding of regulatory expectations and compliance requirements.
• Manufacturing floor experience, including frequent interaction with operators, engineers, and quality teams.
• Strong stakeholder management skills, including the ability to build relationships and collaborate effectively with internal and external partners.
• Clear, concise communication style, particularly when explaining complex issues and proposed fixes to non-technical audiences.
• Ability to remain calm and effective in stressful, time-sensitive situations while maintaining a focus on quality and compliance.

Work Environment

This role operates primarily in a production and manufacturing environment with frequent interaction across functions, including manufacturing operators (both on the line and at their desks), engineering, quality, regulatory, compliance, and suppliers. The position follows a hybrid schedule with four days on site and one remote day per week. Typical working hours start between 7:00 a.m. and 8:00 a.m., with a standard 40-hour workweek. The workday can be fluid, with frequent changes and the need to respond quickly to live production issues and evolving priorities. You will work within a regulated environment, using systems such as TrackWise, MasterControl, and SAP, and engaging in activities related to process validation, equipment qualification, and quality system documentation. The role requires comfort in a high-pressure, time-sensitive setting where collaboration, clear communication, and responsiveness are essential.

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)

Job Type & Location

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

Application Deadline

This position is anticipated to close on Nov 3, 2026.

Workplace Type

This is a fully onsite position in Redmond,WA.

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 adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

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 condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.