Pleasanton Categories:
Statistical Quality Engineer Microchip Biotechnologies
Date Required: ImmediatelyPosition is permanent fulltime
Education Required:
BS in Applied Mathematics, Biostatistics or related field
Experience Required:
? Minimum of 5 years experience in a Production, Manufacturing Engineering, and/or Development environment in Life Science or Molecular Diagnostics instrumentation
? Minimum of 5 years working in ISO 9001 and/or ISO 13485 environments
? Medical Device experience is desirable, but not required
Primary Role:
? Provide statistical data and support to Development and Production Management
? Data mine, collect and present information in a clear, complete manner
? Assist management with interpretation of data and root cause analysis in order to improve each step in the process
Job Responsibilities:
Primary Responsibilities:
? Collect and process production data for statistical modeling, graphic and root cause analysis
? Identify relationships and trends in data
? Prepare data for processing by organizing information, checking for any inaccuracies
? Provide data to management to enable them to make informed decisions
? Evaluate the statistical methods and procedures used to obtain data to ensure validity, applicability, efficiency, and accuracy. Report results of statistical analyses, including information in the form of reports, charts/graphs, and tables.
? Analyze and interpret statistical data to identify significant differences in relationships among any limitations in terms of reliability or usability
? Plan data collection methods and determine the types and sizes of sample groups to be used
? Develop and test experimental designs, sampling techniques, and analytical methods
? Provide instructions for workers collecting and tabulating data
? Participate in the development and performance of failure investigation methods, testing, and analysis; ensure compliance with Risk Management requirements (i.e., ISO 14971:2007)
? Participate in the development and implementation of process validations
Secondary Responsibilities:
? Participate on product or project core teams as required
? Assist in the design of research projects that apply valid scientific techniques and use information obtained from baselines or historical data to structure uncompromised and efficient analyses
? Develop an understanding of fields to which statistical methods are to be applied to determine whether methods and results are appropriate
? Apply appropriate statistical sampling techniques or use complete enumeration bases to determine and define groups to be surveyed
? Provide Supply Chain and Production Floor support, as required
? Conduct trainings as required
? Support the Quality System by writing applicable procedures, developing specifications and other responsibilities, as assigned
Skills Required:
? Strong analytical and problem solving skills
? Analyzing data or information ? Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts
? Interacting with computers ? Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information
? Interpreting the meaning of information for others
? Translating or explaining what information means and how it can be used.
? Documenting/recording information ? Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form
? Experience in mechanical systems, component fabrication and supplier management
Job Knowledge:
? Fluent use of MS Office suite (Word, Excel, Power Point, Project, Visio) and applicable statistical software, as appropriate (i.e., JMP, Minitab)
? Strong written and verbal English communication skills are required.
? Ability to present project design reviews, test reports and research results to internal and external audiences
? Ability to comprehend an extensive variety of technical instructions in mathematical or diagrammatic form
? Utilizes knowledge of business goals and broad understanding of industry activities and technologies to complete tasks
? Develops a working knowledge of internal functions
? Develops a working knowledge of internal functions
? Expertise with Quality Inspection and Process Validation principles and practices
? Familiar with FDA, IS09001, 13485 and 14971 regulatory risk management requirements
Additional Job Abilities:
? Requires the ability to perform independently and as part of a team
? Ability to communicate in a clear, concise, personable manner
? Ability to teach and present in one-on-one or group situations
? High energy and interest in working in a startup environment
Required Interactions:
? Manufacturing
? Quality Control
? Materials
? Research & Development
? Core teams
? Supply Chain
? Distribution
? Receiving
? Warehouse / Inventory
? Customer Service
? Technical Support
? Field Applications
? Service
? Sales
? Marketing
? Project Approval Committee
Working Environment/Minimum Physical Requirements
? Appropriate safety precautions are required in designated areas, laboratories, and customer sites
? Job duties are performed in laboratories and offices
| Location: | Pleasanton, CA United States |
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Microchip Biotechnologies
Investors: Domain Associates, In-Q-TelAll Jobs: at Microchip Biotechnologies
| Web Site: | www.microchipbiotech.com |
|---|---|
| Headquarters: | 6693 Sierra Lane Suite F Dublin, CA 94568 United States |
| Industry: | Biotechnology |
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