*Position: Quality Engineer*
*Location: Carlsbad,CA*
*Duration: 6+ Months*


*NEED A CANDIDATE WITH recent medical device work experience*


· Design, create, verify/validate routine and adhoc reports regarding
various aspects of
complaint activities to a multitude of different departments located in
different locations.
· Designing and maintaining SharePoint sites that are related to Post
Market Vigilance
(PMV) Activities. Information loaded to the site is used by the department
as reference
material, so up-to- date data is essential.
· Build and maintain Access databases used for monthly and adhoc reporting
· Develop and maintain tools for use by business operations where they can
pull data on
demand and tools to assist in their analysis of business operations
· Suggest and implement system improvements based on user requests
· Provide training and administer the Complaint Tracking System (CTS) or
other tools
developed within the team
· Generate T-SQL and Access queries, charts and perform analysis of
complaint data in
support of
· Monthly metrics
· Corporate metrics
· Product Quality Improvement Teams
· Provide technical support to projects related to CTS, as required.
· Support MITG-wide PMV Analytics improvement projects, as required.
· Generate/develop trend reports
· Participate in process improvement projects such as:
· Complaint tracking system improvements
· Provide backup support for other CTS administrators.
· Provide backup support for the corporate monthly metric report
· Assist with various Analytic projects (i.e. data mapping, validation,
database table
assessments, etc).
· Education: Associate Degree or 3+ years of experience in a similar role
· Data management: 2+ years in a data management, statistical, and/or
analytical role in
medical devices, pharmaceuticals, biotechnology or healthcare. Candidates
with data
management, statistical and/or analytical experience from other industries
will be
· Project Management: Small scale project management
· D/B Management: Familiar with T-SQL, Access, Business Objects
· BI Tools: Familiar with BI software/tools such as Tableau, TIBCO
SpotFire, SAS
· Query Writing: Advanced level building queries in Access, SQL or in
similar languages
· Excel Experience: Solid background with standard formula building, nested
IF statements,
standard calculations, Vlookup, Hlookup, charting/graphing, pivot tables
and can build
advanced formulas (macro knowledge is a plus)
· System Validation: 2+ years’ experience validating systems, writing test
preferably in a regulated industry such as biotechnology or healthcare
· SharePoint: Working knowledge of SharePoint sites and is able to build
SharePoint sites
for collaboration and documentation purposes. InfoPath experience a plus.
· Proficiency in Word, PowerPoint, Visio
· Have the ability to write work instructions in an easy to understand
manner for the non-
technical audience.
· Demonstrated ability to communicate clearly both verbally and in writing
· Must be a team player – willing to work with other departments and
· Excellent documentation and communication skills.
· Attention to detail and a commitment to quality work
· Detail oriented and highly organized
· Excellent customer service skills
· Requires some direction but then is able to work with minimal supervision
repeated/similar tasks
· Programming experience a plus
· Knowledge of quality control concepts a plus
· Knowledge of the FDA Quality System Regulations and ISO Quality System
Standards a
· Post-Market Vigilance/Surveillance and/or Patient Safety/Risk Management
experience a


*--Thanks & Regards,Vikas Kumar Singh*

*Okaya InfocomEmail: vikas.si...@okayainc.com <vikas.si...@okayainc.com>*

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