Customer Quality Specialist II
Resume:
JENNIFER L. STOUT
WEST CHESTER, PA *****
484-***-**** *********@*****.***
https://www.linkedin.com/in/jennifer-stout-4b615717/
Medical Devices ● Customer Quality Post Market Surveillance ● Complaint Handling ● Key Account Management ● Surgeon Education & Training
DEPUY SYNTHES, JOHNSON & JOHNSON (WEST CHESTER, PA)
CUSTOMER QUALITY SPECIALIST II 1/2013 – 11/2018
Recruited for independently receiving, documenting, investigating, and coordinating responses on product complaints.
• Directly interfaced with hospitals, surgeons, patients and internal employees for reporting of complaints and adverse events.
• Communicated with Quality Engineers, Manufacturing, Product Development and other functional experts as needed. Reviewed technical evaluations and investigational tasks required for complaint processing for Trauma, Spine, Cranio-maxillofacial, Power Tools and Biomaterials.
• Subject Matter Expert for Class III device (Liaison for Third Party Evaluator), Legal, Literature, Patient Initiated complaints, Investigation Training, and Response Letters. Created and updated work instructions for processes and conducted training.
• Reported Initial and Supplemental Medical Device Reports (MDRs) to the Food and Drug Administration.
• Processed Clinical Study complaints.
• Performed MedDRA coding, parts review, and closure of complaints.
• Performed non-conformance investigations.
• Mentored new hires and colleagues.
• Assisted in department audits which included the Food and Drug Administration.
• Maintained current knowledge of FDA Regulations 21CFR 803, 21 CFR 820.
• Selected to assist in the training of a new complaint management system roll-out.
• Selected to support another division in processing complaints.
• Selected to attend The Pennsylvania Women’s Conference in 2016.
ASSOCIATE KEY ACCOUNT MANAGER 3/2012 – 12/2012
Recruited for building, maintaining, and strengthening relationships between hospital accounts and individual surgeons and the Synthes Spine home office organization.
• Promoted from Key Account Specialist to the role of Associate Key Account Manager.
• Worked with the sales representatives in charge of the respective accounts to develop and implement an optimal engagement plan.
• Facilitated and coordinated activities and interactions between key accounts and all home office executives and staff.
• Secured comprehensive and targeted internal communication and information on all ongoing and planned activities with key accounts.
• Managed segment specific programs to advance and foster relationships with assigned customer accounts.
• Managed the engagement process flow of all assigned key accounts and the customer segment specific programs.
• Recorded all relevant account personnel and their interactions and activities with sales management and corporate personnel.
SYNTHES (PRESENTLY DEPUY SYNTHES, WEST CHESTER, PA)
KEY ACCOUNT SPECIALIST 2/2010 – 12/2012
Selected for defining and implementing concepts, processes and tools necessary to successfully manage hospital and surgeon accounts.
• Promoted from Administrator, Preceptorships and Fellowships to the role of Key Account Specialist.
• Managed the engagement process flow of all assigned key accounts.
• Acted as an internal consultant to facilitate surgeon visits and maximize visit output.
• Managed the process of customer segment specific programs.
• Recorded all relevant account personnel and their interactions and activities with Synthes Sales Management and Corporate personnel.
• Analyzed product usage and sales patterns of accounts.
• Performed timely follow-up on all key account specific communication / activities with Corporate personnel.
ADMINISTRATOR, PRECEPTORSHIPS & FELLOWSHIPS / FORUM REGISTRATION SURGEON EDUCATION & TRAINING (SPINE DIVISION) 9/2004 – 1/2010 Administrator, Fellowship Program, Spine Division
Selected to manage and partner with the AO Foundation to oversee all fellowships for the Spine Division.
• Communicated with institutions and processed applications and progress reports.
• Processed and distributed payments and maintained master budget for program and processed reports on activity and budget.
• Maintained database of Fellows.
Administrator, Preceptorship Program, Spine Division Selected to create and lead a successful preceptorship program and act as a model for other divisions.
• Promoted from Administrator, Spine Division Forum Registration to the role of Administrator, Preceptorship Program, Spine Division.
• Constructed policy, forms and monitored budget for program.
• Communicated with company travel agency, field sales personnel, and hotels nation-wide.
• Processed the induction of new Preceptors (teaching surgeons) into the program.
• Maintained database of Preceptors and created and maintained webpage for program.
• Processed over five-hundred plus visits since program inception. Administrator, Forum Registration, Spine Division
Recruited to manage registration and budgeting for all of the division’s training and educational programs for surgeons.
• Processed forum registrations (fifty plus programs/year) to include wait-lists, pre-commitments, no- shows, cancellations and course transfers, including web-based and manual registration.
• Performed follow-up communication with participants and field sales personnel (400+) ensuring attendance confirmations.
• Responded to registration inquiries from participants and field sales personnel.
• Processed and communicated pre/post-registration reports.
• Coordinated packing and unpacking and prepared necessary documents for all forums.
• Expedited check requests for honorariums and surgeon reimbursements and maintained department’s master budget.
• Consultant for position from September, 2004 and hired in March, 2005.
SKILLS
CATSWEB, ETQ, AND UNITY (SALESFORCE.COM) COMPLAINT MANAGEMENT SYSTEMS, MICROSOFT OFFICE
EDUCATION
NORTHWESTERN STATE UNIVERSITY OF LOUISIANA Bachelor of Science, Psychology
AWARDS
2015 J&J Ten Year Service Award
2015 J&J Encore Award for Exceptional Performance
2016 J&J Encore Award for Exceptional Performance
2018 Two (2) J&J Encore Awards for Exceptional Performance
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