Senior Quality Assurance Engineer

Job Title: Senior Quality Assurance Engineer Location: Redmond, Washington Type: Contract Compensation: $65.00 - $70.75/hr Work Model: Hybrid Hours: 7:30 AM–5/6 PM (4 days onsite 1 day remote)

Overview

.Global Medical Device company looking to hire experienced Engineer to their team. Must bring experience with Root Cause Analysis, Non Conformances, and CAPAs. This is not an IT Role. Must bring experience on a manufacturing floor.

Responsibilities

• Work closely with Operations and the business functions to ensure quality performance of product and processes.
• Non-Conformances
• Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
• 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.
• Supplier Activities
• 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.
• Process Improvements/Validation
• 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.
• Perform other related duties as assigned.

Requirements

• Bachelors of Science in Engineering or related Science
• 3+ years of experience
• Ability to conduct detailed reviews of validation documentation, PPAPs, and supplier changes
• Strong root cause analysis experience, with formal RCA preferred
• Strong problem-solving and organizational skills in a fast-paced environment
• Clear communicator who can effectively manage priorities and stakeholders
• Highly detail-oriented and able to work independently
• Ability to lead and collaborate with cross-functional teams

Preferred

• Manufacturing and formal validation experience strongly preferred
• Experience from Medical Device or other regulated industry

System One, and its subsidiaries including 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.

#LI- Ref: #558-Scientific