Senior Quality Assurance Engineer

System One; Washington (District of Columbia); On-site; USD 83,000 - 98,000; Full time

Job summary

System One is seeking a Senior Quality Assurance Engineer for an onsite role in Redmond, Washington. The engineer will drive QA methods, lead CAPA/NCR activities, and collaborate with suppliers and internal teams to improve product quality.

The position requires a bachelor’s degree in Engineering with at least 3 years of experience in QA, and a strong background in regulatory interactions. Onsite work four days per week and a standard 8:00 AM to 4:30 PM schedule are provided.

Qualifications

• Bachelor’s degree in Engineering is required.
• Minimum 3 years of experience in QA or related field.
• Experience in compliance risk situations and regulatory interactions.

Responsibilities

• Develops and implements methods for process control, testing and inspection to ensure products are flaw-free and meet design.
• Analyzes reports and defective products to identify trends and drive corrective actions.
• Collaborates with suppliers and internal teams to address quality issues and improve supplier quality programs.
• Maintains KPIs for process/product quality and analyzes trends to trigger corrective actions.

Skills

Project management

Regulatory awareness

Education

Bachelor’s degree in Engineering

Job description

Job Title

Senior Quality Assurance Engineer

Location

Redmond, WA

Contract Type

Contract

Compensation

$60 - $70.81/hr

Work Model

Onsite (4 days per week)

Hours

8am-4:30pm M-F

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.
• 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.
• 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

• Bachelor’s degree in Engineering
• Minimum 3 years experience required
• Project management experience
• Experience working in a compliance risk situation
• Experience in interacting with regulatory agencies

Company Overview

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.