Amazon Sr Auditor Quality & Lean Manufacturing 

United States, California, Sunnyvale 

337851622

Key job responsibilities
As a senior auditor, you will use your work experience, in consumer electronics and medical devices development and manufacturing, to conduct and/or lead audits per regulatory requirements, industry standards, and Amazon Devices and Services expectations. Your role is to capture actionable insights that promote continuous improvement of product quality processes and operations. For the audits you conduct, you are responsible for all phases of the audit, including preparation, planning, conducting audits, reporting, and driving corrective actions and preventative actions to resolution. For the audit program, you will support its continuous improvement initiatives and help ensure the program meets business expectations.A day in the lifeSunnyvale, CA, USA

- 5+ years of program or project management experience
- Experience using data and metrics to determine and drive improvements
- Experience owning program strategy, end to end delivery, and communicating results to senior leadership
- Certified Lead Quality Auditor for ISO 9001 and ISO 13485 current standards
- 5+ years work experience involving auditing of consumer electronics or medical devices (specifically: 21 CFR 820, 21 CFR Part 11, 21 CFR 803 and 806, clinical trials or other FDA regulations)
- Excellent written and verbal communications skills
- Bachelor’s degree Mechanical Engineering, or another STEM field

- Master's degree
- Prior experience as a quality auditor of factory operations
- 5+ years developing and executing Audit Plans (in a cross functional organizations), conducting Quality Audits (internally and supplier), writing Audit Reports and verifying effectiveness of the Corrective Actions
- 3+ year experience preparing audit executive summaries and presenting results to C-Suite executives
- Excellent organization skills with ability to prioritize and manage to critical project timelines in a fast-paced environment
- Prior experience as quality management systems auditor in medical device industry
- Prior experience as corporate QMS internal auditor
- Six Sigma Green Belt