• Bachelor's degree in a technical field such as engineering, quality assurance, or a related discipline
• 5+ years of experience in a quality assurance role, preferably in an electromechanical or manufacturing environment
• Experience with quality system documentation and record-keeping
• Experience in quality management principles, tools, and techniques

We are a passionate team of doers that apply cutting-edge advances in technology to solve real-world problems and transform our customers’ experiences.

As a Quality Assurance Administrator, you will be a key member of a unique and talented team responsible for developing exciting new products for our customers. In this role, you will collaborate closely with cross-functional teams across the organization. Reporting to the Quality Manager, the Quality Assurance Administrator will be responsible for administering and maintaining the quality management system to support the production of electromechanical devices and consumables. This will involve reviewing and approving various quality system and production records, as well as assisting in the generation of quality documentation.

The ideal candidate will have experience as a Quality Assurance professional, with a track record of supporting the production and commercialization of complex electromechanical products or similar manufactured goods. You will bring great knowledge of quality management principles, tools, and techniques, as well as familiarity with quality systems such as ISO 9001 or ISO 13485 and proficiency with quality records which includes CAPAs and NCMRs

In this role, you will work closely with teams in Engineering, Manufacturing Engineering, and Operations to ensure quality standards are upheld throughout the product lifecycle. with great communication skills and the ability to collaborate cross-functionally will be key to your success.

If you are an experienced Quality Assurance professional looking to join an innovative team developing cutting-edge products, this is an excellent opportunity to make a meaningful impact.

Key job responsibilities

• Review and approve quality records such as incoming inspection, supplier files, and lot history records.
• Review for completeness quality records such as CAPAs, NCMRs, and Complaints.
• May perform or assist complaint or CAPA investigations, and / or complete CAPA effectiveness checks.
• Maintain the approved supplier list and work with suppliers to obtain the required documentation.
• May perform or assist with supplier auditing, including desktop and on-site factory audits.
• Administer and/or assist in administering and maintaining the training and document (paper & electronic records).
• Maintains controlled documents (paper & electronic records), including but not limited to training records, change orders, document revisions, supplier records, purchase orders, receiving records, inspection records, NCMRs, CAPAs, complaints, etc.
• Administer and/or assist in administering the CAPA and complaint systems
• Supports internal and external audit follow-ups, issue tracking and closure
• Supports, prepares, provides Quality training / New Employee Quality System training with cross functional teams as assigned.
• Assist QA management in monitoring and driving key performance quality metrics
• Ensure quality directives and policies are effective and implement action to ensure compliance

About the team
Innovators wanted! Are you an entrepreneur? A builder? A dreamer? This role is part of an Amazon Special Projects team that takes the company’s Think Big leadership principle to the extreme. We focus on creating entirely new products and services with a goal of positively impacting the lives of our customers. No industries or subject areas are out of bounds. If you’re interested in innovating at scale to address big challenges in the world, this is the team for you.

We are open to hiring candidates to work out of one of the following locations:

Milpitas, CA, USA

• Experienced in Microsoft Office, Adobe Reader/Pro, and ePLM/eQMS systems and the ability to convert documents within systems
• Ability to support cross functional teams in a fast-paced, high regulated environment
• Familiarity with quality systems such as ISO 9001, ISO 13485, or similar
• Strong attention to detail and problem-solving skills
• Strong communication and collaboration abilities to work effectively across teams

Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $91,200/year in our lowest geographic market up to $185,000/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit https://www.aboutamazon.com/workplace/employee-benefits. This position will remain posted until filled. Applicants should apply via our internal or external career site.