Quality Engineer

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 escalate Supplier Corrective Action Requests (SCAR) as required.
• 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)

Workplace Type

This is a fully onsite position in Redmond,WA.

Application Deadline

This position is anticipated to close on Sep 4, 2026.