CFQ Specialist

 
Location: Mounds View, Minnesota
Posted On: 4/18/2017
Job Code: CFQ Spec_Mounds View
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Category:IT code:new HBR
 
Job Description
 
Position Description:
The Customer Focused Quality (CFQ) Specialist is a project leader of cross-functional teams that successfully manages every aspect of the Field Corrective Action (FCA) or recall process. The Prin. CFQ Specialist facilitates the development and review of Field Advisory or Recall Notices sent to customers to mitigate the impact of product quality issues on patients. Among other responsibilities, the person in this role identifies and develops process improvements to increase effectiveness, efficiency and compliance. This position involves coordination with a diverse group of people in the following areas: legal, Sr. quality leadership, reliability engineers, supply chain, marketing, etc… Other duties may be assigned.

Position Responsibilities:
• Lead cross functional teams to facilitate the development, review and approval of global Field Corrective Action (FCA) Plans.
• Define recall strategy and actions that are compliant with all applicable regulations and internal procedures to properly address a product quality issue.
• Facilitate the development of FCA materials (letters, presentations, etc…) to effectively communicate relevant information to appropriate customers (e.g. health care providers, risk managers, hospital personnel, patients) and client's field personnel to mitigate patient risks.
• Identify FCA strategies, actions and milestones to be included in the FCA plan.
• Negotiate resolution of issues impacting FCA planning.
• Work with regulatory contacts to identify, plan and coordinate notifications to regulatory bodies and respond to regulatory and field inquiries in a timely fashion.
• Oversee the global execution of the global FCA plan to ensure adherence to plan actions and milestones.
• Analyze current business processes and identify best practices to develop improved, standardized processes for Product Hold Orders (PHO) and FCAs.
• Coordinate with different stakeholders in supply chain and quality to initiate, execute, reconcile and close Product Hold Orders
• Assist in the response to regulatory inquiries related to Field Corrective Actions
• Ensure that the FCA plan follows all applicable internal, corporate and regulatory standards or requirements.
• Provide support for internal and external inspections. May present information directly to internal or external auditors.
• Maintain data and prepare reports, presentations, proposals and status updates for management.

Basic Qualifications :
• Bachelor’s degree with 7 to10 years of professional experience (post-degree) or Master Degree with 5 to 8 years of experience.
• Project/Program management experience with ability of managing multiple projects simultaneously.
• Experience developing effective written communications and executive presentations
• Experience analyzing and reviewing large amounts of data and spreadsheets, preparing reports
• Energetic individual with ability to work under pressure and with tight deadlines
• Advanced skill level for MS Office suite of products (Excel, Word, PowerPoint)

Desired/Preferred Qualifications:
• Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive.
• Strong attention to detail.
• General knowledge of Database Systems such as SAP, Siebel, Factory Works.
• Demonstrated ability to work without appreciable direction. Exercises considerable latitude in determining objectives and approaches to assignment.
• Effective at influencing and building strong working relationships across all levels and diverse cultures
• Experience in at least one of the following roles: IT Business Systems Analyst/Change Management Specialist/Process Improvement/Black Belt/Database Management/Customer Service Data Analyst/Project Manager
• Demonstrate high technical skills; apply sound engineering judgment, technical writing skills, statistical skills, and critical thinking
Category:IT  code:new
 
 
Job Requirements
 
 
MS Word, MS Office, Compliance, Management, Siebel, Engineering, Marketing, Systems Analyst, ISO 9001, Program Management, Database Management, Project Management, MS Excel, SAP
 

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Contact Details
 
Recruiter
Chirag Sharma
 
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