Responsible for oversight & management of Quality Management System (QMS) database for supplier quality globally, including supplier corrective action, supplier change notifications, and supplier files. Responsible for reporting of metrics from the database and support of system changes and/or validations. Responsible for development of training materials for new hires requiring access to the database.
Job Functions / Key Responsibilities:
* Subject Matter Expert on software system used for management of supplier files and approval of parts & services globally.
* Provide first-level help desk support to users, including process coaching and troubleshooting system issues, (e.g., system access, systems response) before escalating to IT if needed.
* Collect and generate metrics, reporting to upper management on process & supplier performance.
* Create user procedures for system step guides.
* Develop end user workshops and rollout trainings.
* Develop technical specifications for purposes of validation and verification.
* Identify and recommend opportunities for improvement related to current business processes and systems (i.e. new metrics, metric optimization, data verification, new data repositories and/or extraction methods).
* Meet with users to confirm business needs and develop reporting specifications and functionality, as well recommending other functionality.
* Initial / Final Reviewer of System Inputs
* Provide first level assessment of records, documentation, and electronic submissions prior to routing for approvals.
* Final reviewer of change packages for completeness prior to closure within the database.
* Management of supplier notification of changes assuring proper dissemination of information.
* Monitor system changes impacting metrics reporting from input systems
Education / Skills / Experience:
* Bachelor's degree required (degree with emphasis in Information Technology or Biosciences is preferred).
* Minimum 5 years of experience supporting enterprise level applications
* Experience with Enterprise information systems such as Qlikview Technologies, ERP (such as JDE, SAP), PLM (TeamCenter, Agile), QMS (such as ETQ Reliance, Pilgrim, TrackWise, Master Control) preferred
* Experience managing CAPAs and Non-Conformances is preferred
* FDA regulations for lifesciences, medical devices, and pharmaceutical companies preferred
* Excellent verbal and written communication skills a must.
* Excellent organizational skills and a self-starter needed.
* Ability to adapt to changing requirements.
Discover Our Benefits:
* Amenities include: fitness room, basketball court, volleyball sand court, ping pong, intramural sports leagues, modern cafeteria, Starbucks coffee kiosk, on-site credit union, etc.
* Medical, dental, and vision insurance
* 401k Matching
* Life and disability insurance
* Health care and dependent care flexible spending accounts and health savings accounts
* ESPP (Employee Stock Purchase Plan)
* Generous paid time off (company holidays, vacation days, sick days, and one week holiday paid time off at the end of the year between Christmas and New Year's)
* Adoption assistance
* Back-up dependent care
* Education reimbursement program
* Supplemental benefits including homeowner's, insurance, auto insurance, and legal services
* Resources for living (employee assistance program)
* Plus REwards Program (home buying/selling cash back rewards program)
* Total Wellness Program
* Rideshare/Van Pool
* Casual dress code
About Edwards Lifesciences
Edwards Lifesciences is an American medical equipment company specializing in artificial heart valves and hemodynamic monitoring.