Senior Quality Assurance Engineer

Job Title: Senior Quality Assurance Engineer

Location: Redmond, Washington

Type: Contract

Compensation: $65-73/hr

Contractor Work Model: Hybrid – onsite and remote

Overview

Join a collaborative and innovation-driven medical technology organization as a Senior Quality Assurance Engineer, where you'll play a key role in ensuring product quality, supplier performance, and manufacturing excellence. This hybrid contract opportunity offers hands-on involvement with quality systems, CAPA investigations, supplier quality initiatives, and cross-functional process improvements in a fast-paced, highly regulated environment. Ideal for a proactive problem-solver who enjoys driving continuous improvement and making a direct impact on product reliability and patient outcomes. This position focuses on physical products and manufacturing processes rather than software or IT quality assurance.

Responsibilities

• Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
• Analyzes reports and defective products to determine trends and recommend corrective actions.
• Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.
• Work closely with Operations and the business functions to ensure quality performance of product and processes.
• Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.
• Support execution and analysis of manufacturing related complaint investigations and product field actions.
• Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
• Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
• Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval.
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
• Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
• Engage in the development and improvement of the 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 potentially lead the creation and/or review of new or modified procedures.
• Support the development and review of process and equipment validation/qualification and MSA of internal processes.
• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

Requirements

• Strong in critical thinking and “out of the box” thinking
• Demonstrated ability to work independently and as part of cross-functional teams
• Ability to manage multiple tasks simultaneously
• Bachelor’s of Science degree, strongly preferred in Engineering
• Minimum of three years experience in a related field

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific