Quality Systems Analyst
17425 NE Union Hill Road, Suite 150 Redmond, WA 98052
Position Title: Quality Systems Analyst
Position Description: Protingent Staffing has an exciting contract opportunity with our client in Redmond Washington for an experienced Quality Systems Analyst.
- Support compliance to the Quality Management System (QMS) within the facility, by providing effective support, training and guidance to all employees.
- Assist with creating and presenting QMS trainings (e.g., CAPA process, PLM, Internal Audits)
- Act as Quality Liaison, working with CAPA Owners, to ensure compliance to program requirements and effective outcomes.
- Aid in the performance of internal audits, in a Lead Auditor capacity, to assure that quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.
- Assist with the continual collection of data and bi-annual collection of QMS data and associated metrics
- Assist with bi-annual Management Review Meeting coordination and slide deck preparation
- Support Document Control functions (e.g., Change Order and Deviation reviews, Assignment of Employee Training)
- Effectively support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
- 5+ years’ quality experience, within in regulated (Medical Device) environment.
- Advanced knowledge of ISO 13485: 2016 or equivalent required.
- 2+ years’ experience conducting Root Cause Investigations, Project Management, and/or Green/Black Belt certification highly preferred
- Excellent organizational, interpersonal communications and presentation skills required.
- High level of personal/and professional integrity and trustworthiness with a strong work ethic.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.
Benefits Package: Protingent offers competitive salary, 100% paid health insurance, education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.