Sr. Quality Management System Auditor

Job description

DESCRIPTION

Amazon Lab126 is an inventive research and development company that designs and engineers high-profile consumer electronics. Lab126 began in 2004 as a subsidiary of Amazon.com, Inc., originally creating the best-selling Kindle family of products. Since then, we have produced groundbreaking devices like Fire tablets, Fire TV and Amazon Echo. What will you help us create?

The Role:
As a Senior Internal Quality Auditor you will participate in the development, maintenance and continuous improvement of the Amazon Lab 126 Quality Management System. Auditing activities cover all phases of the audit, including preparation and planning, conducting audits, reporting on audit findings, driving corrective actions and verification of audit findings across the organization.

The audit process addresses all aspects of the Product Development Lifecycle covering Hardware and Software development, together with supporting functions, including: Manufacturing Operations, Program Management, Supply Chain, Materials Management, Quality Engineering, Supplier Quality, Forward & Reverse Logistics, and Configuration Management.

Duties and Responsibilities:
· Audit internal policies, QMS documents, KPIs and business systems for accuracy and effectiveness against internal and external Quality System Requirements.
· Analyze audit data to identify trends and issue reports & recommendations to management.
· Support third party audits
· Develop and manage the Internal Audit CAPA program. Lead the CAPA Board meetings and ensure follow-up on all CAPAs to closure.
· Develop and present metrics around audits and CAPAs to optimize the audit process and strengthen continuous improvement opportunities across the organization.
· Ensure audit records are complete and accurate.
· Mentor and train new auditors.
· Train process owners and stakeholders on QMS and 3rd party requirements.
· Create and revise QMS documentation and instructions based upon audit findings as necessary.

PREFERRED QUALIFICATIONS

· General understanding of US FDA Quality System Requirements (CFR 820)
· Six Sigma Master Black Belt
· Certified Quality Manager ASQ
· Experience of Kaizen principles SCRUM Methodology (or equivalent) and Lean/Six Sigma principles experience
· Master’s in Business, Operations Management, System Analysis/Computer Science or related field

Lab126 is part of the Amazon.com, Inc. group of companies and is an Equal Opportunity-Affirmative Action Employer – Minority/Female/Disability/Veteran/Gender Identity/Sexual Orientation

Desired profile

BASIC QUALIFICATIONS

· Bachelor’s degree Business, Operations Management, System Analysis/Computer Science or related field
· Certified Quality Auditor - ASQ
· Registered Lead Assessor for ISO 9001, AS9100, and / or ISO 13485
· Minimum of 5 years conducting Internal Quality Audits, writing Audit Reports and verifying effectiveness of the Corrective Actions
· Experienced in developing and executing Audit Plans within a cross functional organization
· Experienced in conducting Supplier Audits across a variety of industry sectors
· Writing and developing QMS procedures and documentation
· Developing and presenting QMS training materials
· Six Sigma Green Belt
· Strong written and verbal communications skills
· Strong organization skills
· Ability to work independently and collaboratively
· Experience with Microsoft Office applications such as Excel and Visio
· Ability to prioritize and manage to critical project timelines in a fast-paced environment