Quality Inspector

Job description

DESCRIPTION

Amazon is focused on protecting the health and safety of our employees while continuing to serve people who need our services more than ever. Regular testing on a global scale across all industries would both help keep people safe and help get the economy back up and running. But, for this to work, we as a society would need vastly more testing capacity than is currently available. Unfortunately, today we live in a world of scarcity where COVID-19 testing is heavily rationed. Until we have an effective vaccine available in billions of doses, high-volume testing capacity would be of great help, but getting that done will take collective action by NGOs, companies, and governments.

For our part, Amazon has begun the work of building incremental testing capacity.

Primary Responsibilities:

· Responsible for factory shop floor quality control including manufacturing batch record handling & disposition
· Conduct continuous Quality Control Checks, In-Process Inspections, Quality Data entry for the production operations
· Author and review and conduct training on SOPs and Responsible for recording SOP deviations, recording process deviations, lead problem identification/solving and continuous improvement activities in the production process with all involved areas of the site.
· Resolve process deviations with investigations, including determining and issuing appropriate Corrective Actions/Preventive Actions (CAPAs) and CAPA effectiveness reviews
· Schedule and perform quality audits and ensure timelines for audit steps (pre-work, conducting audit, issuance of audit report, corrective action and preventive action receipts) meet established expectations. Follow up on the appropriate action to address any audit findings.

This is supporting 2nd shift (2pm-10pm)

PREFERRED QUALIFICATIONS

· Thorough understanding of Quality Management Systems (i.e ISO 13485) and current awareness of regulatory expectations and requirements
· Experienced in Lean Manufacturing, Manufacturing Process Control and/or Six Sigma
· Experience performing quality audits
· Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines
· Ability to work independently with limited supervision in a virtual-management environment
· Must possess "Subject Matter Expertise", including knowledge and demonstrated application in
· Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization
· Demonstrated ability to establish and maintain collaborative relationships with key stakeholders, driving results/impact for critical business / compliance initiatives.
· Demonstrated ability for process improvement and to create/implement simple, compliant systems in diverse areas.
· Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact

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.

Desired profile

BASIC QUALIFICATIONS

· Bachelor's Degree in Science, Chemistry, (Micro-) Biology, Engineering or equivalent
· Minimum of 2 years of manufacturing, laboratory, technology, or quality operation experience within FDA or similarly regulated industry