- Puteaux, France
• 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.
• Ensure that processes needed for the quality management systems (ISO 15189, 21 CFR Part 493 CLIA, CAP) are established, implemented, and maintained.
• Creating, updating, reviewing and developing QMS standard operating procedures (SOPs) and other supporting work instructions per CLIA, CAP and other state regulations.
• Support internal and external audits (CLIA, CAP, supplier, customer/partner), and coordinate appropriate action with all the impacted site teams on major and critical audit findings
• Provide technical leadership to implement quality processes including statistics-based variation reduction, control planning, mistake proofing, and Laboratory Process Control.
• Resolve process deviations with investigations, including determining and issuing appropriate Corrective Actions/Preventive Actions (CAPAs) and CAPA effectiveness reviews
• Analyze process capability data and other quality metrics to ensure that processes meet expectations
• Responsible for Control Plans and Failure Mode & Effects Analysis (FMEA) on all validated systems.
• Schedule and perform assigned laboratory audits and ensure timelines for audit steps (pre-work, conducting audit, issuance of audit report, corrective action and preventive action receipts) meet established expectations. Maintain industry current knowledge, application, and certification status for various technical and quality auditing topics.
• Develop continuous improvement initiatives including evaluation of current operations, data analysis and implementation of recommended solutions.
• Develop capacity requirements for current and future operations and design/implement solutions to support capacity needs
• Develop best practices, routines and innovative solutions to improve production rates and quality of output
• Perform process and design simulations and analysis
• Establish Poka-yoke standards and drive implementation in the most valuable areas (based on problem solving)
• Leads Process Improvement tools and methods (for example, 5S, root cause analysis, six sigma, time and motion studies) to eliminate
• Accountable for establishing tracking mechanisms for KPIs that will increase throughput and driving improvement plans across all shifts/lines
• Masters Degree in Engineering or equivalent
• Minimum of 3 years of manufacturing, laboratory, technology, or quality operation experience within FDA, CAP CLIA or ISO regulated industry
• Experience in laboratory, technology, or quality operation experience within FDA, CAP, CLIA or similarly regulated industry
• Fluency in Lean Manufacturing, Manufacturing Process Control and/or Six Sigma
• Experience conducting FMEAs/ Risk Management and performing audits of testing laboratories
• Ability to work independently with limited supervision in a virtual-management environment
• Demonstrated ability for process improvement and to create/implement simple, compliant systems in diverse areas.
• Experience delivering training/information to peers, hourly associates, and senior management, both individually and in groups
• Experience delivering messages related to performance
• Ability to give and receive feedback effectively
• Evidence of ability to prioritize, manage and complete projects with tight deadlines
• Ability to adapt well to fast-paced environments with changing circumstances, direction, and strategy
• Desire to thrive in a dynamic, growing environment
• Previous Kaizen/Continuous Improvement experience
• Willingness to work different shifts
Note: This position requires sustained work in a laboratory that will be receiving biological specimens that may include viruses for infectious diseases, including the COVID-19 virus (which is known to cause the coronavirus disease). Accordingly, this role involves the risk of infection. Amazon has implemented appropriate safety policies, training, processes, and equipment as per applicable guidelines.
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.
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