Quality Engineer

Job Title: Quality Engineer

Job Description

This role focuses on ensuring the consistent quality performance of products and processes within a manufacturing environment. The Quality Engineer works closely with Operations and cross-functional business teams to manage non-conformances, drive corrective and preventive actions, support supplier quality activities, and improve internal manufacturing and distribution processes. The position involves frequent interaction with stakeholders across the organization and suppliers, with a strong emphasis on root cause analysis, documentation, validation, and continuous improvement.

Responsibilities

• Work closely with Operations and business functions to ensure high-quality performance of products and processes across manufacturing and distribution.
• 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 Preventive Action (CAPA) records, ensuring timely processing and closure within the electronic quality management system (TrackWise).
• Support the execution and analysis of manufacturing-related complaint investigations and product field actions, ensuring appropriate documentation and follow-up.
• Investigate internal non-conforming product within the Material Review Board (MRB) process and issue non-conformance records 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 to assess and approve changes.
• 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 implement opportunities for supplier part certification to improve quality and efficiency.
• Engage in the development and improvement of internal manufacturing and distribution processes for existing products, focusing on quality and reliability.
• 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, review, and improvement of new or revised procedures related to quality and manufacturing processes.
• 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 initiate appropriate actions based on findings.
• Review and support validation protocols and reports to ensure they meet regulatory and internal quality requirements.
• Review process and equipment validation documentation to confirm compliance and robustness of manufacturing processes.
• Conduct label reviews and support change orders to ensure accurate and compliant product labeling and documentation.
• Perform documentation reviews to ensure completeness, accuracy, and alignment with quality system requirements.
• Lead discussions and influence stakeholders to align on quality issues, resolutions, and improvement initiatives.
• Provide clear direction during quality events to help quickly resolve issues and support the resumption of production.
• Work effectively in stressful, time-sensitive situations, maintaining focus on root cause analysis and sustainable corrective actions.
• Perform other related duties as assigned to support the broader quality systems and operations.

Essential Skills

• Strong experience in root cause analysis and problem-solving within a manufacturing or quality environment.
• Demonstrated ability to manage Non-Conformances (NC) and Corrective Action Preventive Action (CAPA) records.
• Experience working with electronic quality management systems such as TrackWise for nonconformances, CAPAs, and complaints.
• Ability to lead discussions and influence stakeholders at various levels, including Operations, Engineering, Regulatory, Compliance, and Suppliers.
• Strong communication skills, especially when explaining resolution plans and quality decisions to technical and non-technical stakeholders.
• Ability to work both independently and collaboratively within cross-functional teams.
• Comfort working in stressful, time-sensitive situations while maintaining attention to detail and quality standards.
• Experience or familiarity with manufacturing quality, continuous improvement, or supplier quality activities.
• Ability to define requirements and collect objective evidence to support quality decisions and validations.
• Capability to perform and interpret quality data analysis, monitor KPIs, and identify trends.
• Comfort interacting frequently with manufacturing operators, engineers, regulatory and compliance personnel, and suppliers.

Additional Skills & Qualifications

• Engineering or science degree (Bachelor’s degree preferred).
• Experience in a regulated industry, such as medical devices or similar, is preferred but not required.
• Medical device experience is preferred but not required.
• Experience on a manufacturing floor is highly desirable but not required.
• Exposure to or experience with process and equipment validation activities.
• Experience with validation protocols and reports, including process validation and equipment qualification.
• Familiarity with DFMEA (Design Failure Mode and Effects Analysis) and PFMEA (Process Failure Mode and Effects Analysis).
• Experience with control plans and process flow diagrams.
• Knowledge of Production Part Approval Process (PPAP) is a plus.
• Experience using TrackWise for managing nonconformances, CAPAs, and complaints.
• Experience using MasterControl for document management is beneficial.
• Familiarity with SAP for order management, holds, and manufacturing systems is helpful; SAP experience is preferred but can be trained.
• Background in bioscience or laboratory work, with strong technical thinking and stakeholder management, is advantageous.
• Demonstrated ability to translate technical or laboratory skills into practical manufacturing quality work.
• Naturally curious and investigative mindset, with a strong focus on understanding issues deeply.
• Proven execution speed and ability to pivot quickly to provide direction and support production recovery.

Work Environment

The role is primarily on-site, with four days in the facility and one day remote each week. The Quality Engineer works in a manufacturing environment with frequent interaction on the production floor as well as at desks and in meeting spaces. Typical working hours are approximately 7:30 AM to between 5:00 PM and 6:00 PM, with flexibility based on workflow rather than a rigid schedule. The position involves regular collaboration with manufacturing operators, engineering, regulatory, compliance, and supplier teams. The work environment includes the use of electronic quality and document management systems such as TrackWise and MasterControl, as well as enterprise systems like SAP for order and manufacturing management. The role requires comfort working in a dynamic, time-sensitive setting where priorities can shift quickly and quality issues must be addressed promptly.

We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.

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. This temporary role may be eligible for the following: 

· Medical, dental & vision 

· 401(k)/Roth

· Insurance (Basic/Supplemental Life & AD&D) 

· Short and long-term disability 

· Health & Dependent Care Spending Accounts (HSA & DCFSA) 

· Transportation benefits 

· Employee Assistance Program 

.Time Off/Leave (PTO, Vacation or Sick Leave)

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

The pay range for this position is $64.52 - $70.81/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 Jun 18, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 actalentaccommodation@actalentservices.com 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.

Salary : $65 - $71