Senior Engineer, Quality Assurance Engineering - Individual Contributor

Senior Engineer, Quality Assurance Engineering - Individual Contributor

As a Senior Engineer in Quality Assurance Engineering, you will be integral in ensuring the quality performance of our products and processes. You will collaborate closely with operations and business functions to address and resolve quality issues, and manage non-conformances and corrective actions effectively.

Responsibilities

• Work closely with Operations and business functions to ensure quality performance of products and processes.
• Collaborate with internal cross-functional and supplier teams to address top quality issues.
• Own and manage internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA) through the electronic management system, Trackwise.
• Support the execution and analysis of manufacturing-related complaint investigations and product field actions.
• Investigate and manage internal non-conforming products within MRB, issuing NCs as appropriate.
• Communicate and collaborate with suppliers regarding non-conformances and escalate Supplier Corrective Action Requests (SCAR) as required.
• Manage Supplier Initiated Change Requests (SICRs) and engage with cross-functional teams for assessment and approval.
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
• Collaborate with stakeholders to identify and execute opportunities for supplier part certification.
• Engage in the development and improvement of internal manufacturing and distribution processes.
• Perform critical assessments and qualifications of change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
• Participate in and potentially lead the creation and review of new or modified procedures.
• Support the development and review of process and equipment validation/qualification and Measurement Systems Analysis (MSA) of internal processes.
• Maintain KPIs for monitoring process and product quality, perform analysis, interpret trends, and activate appropriate actions as necessary.
• Perform other related duties as assigned.

Essential Skills

• BA Degree in Science/Technical field or related field.
• Minimum of 3 years of experience in quality assurance or related field.
• Experience in Operations/Manufacturing and CAPA.
• Proficiency in TrackWise, ERP Systems, and MS Suite.
• Strong skills in multi-tasking, communication, and problem-solving.

Additional Skills & Qualifications

• Knowledge of Power BI is a plus.
• Quality background with CQE and/or LSSGB certification.
• Experience in the medical device industry with understanding of US and International Medical Device Regulations.
• Familiarity with GDP, GMP, and experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
• Knowledge of key Quality concepts such as Risk Management, CAPA, Audits, and Statistics.
• Project management, leadership, and influencing skills.
• Ability to manage multiple tasks simultaneously in a matrix organization.
• Proficiency in computer literacy, including Excel, Databases, ERP Systems, Trackwise, and Statistical software packages.

Work Environment

The position supports the 2nd shift, operating from 3:30 pm to 2:00 am, Monday through Thursday. The work environment is fast-paced, dynamic, and time-critical, suitable for individuals capable of thriving under such conditions.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $44.00 - $50.00/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)

Workplace Type

This is a fully onsite position in Redmond,WA.

Application Deadline

This position is anticipated to close on Oct 21, 2025.