I bring a broad background in operations, complaint handling and employee management. Enthusiastic team player dedicated to process improvements and staff development.
Recruitment and talent development
Group Lead Complaint Handling , 06/2013
to Current DePuy Synthes – Warsaw,
Responsibility leading 10 full
time direct employee including 4 Clinical Complaint Specialists. Plan and guide each report
through their individual career development plan within WorkDay.
Conduct mentor and coaching
sessions monthly with each direct employee to ensure they are meeting
their outlined Goals and Objectives
Staffing of temporary resources
for Complaint Handling Intake and Review and Closure functions within
Communication of any changes or
updates with staff through email, department meetings, or on a one-on-one
Subject Matter Expert for
Complaint Handling for Customer Quality Department for audits
Responsible to conduct year end
compensation and salary planning for staff.
Responsible for analyzing and
investigating complaint information to ensure complaints are adequately
addressed in a timely manner.
Lead the transition of moving
to an electronic database for complaint information
Maintains and continually
improve the complaint process to ensure that problems reported are
recorded and investigated promptly, reports required by FDA regulations
are filed within the prescribed time limits, and issues identified are
address through coordination with the appropriate business
Assists with the development
and management of the Customer Quality departmental budget
Collaborate with other groups
such as engineering, clinical, medical safety, regulatory, research and
marketing to ensure a thorough and accurate complaint investigation and
Supports the facility in
identifying and eliminating compliance risks. Partners with appropriate
functional departments to achieve effective corrective action.
Serves as a liaison between the
quality assurance department and other departments to ensure timely and
accurate completion of complaint investigations and MDR reports and
summarizes results and makes suggestions for changes.
Complaint Handling Analyst/Specialist, 04/2012
to 06/2013 DePuy Synthes – Warsaw,
product complaint program and complaint analysts with activities related to
complaint investigations including initial assessment and identification of
complaints related to adverse events.
Responsible for analyzing incoming product
complaints, the determination of requirements for investigation, the
investigation and evaluation of complaints, and for finding solutions to
customer issues by working interactively with cross functional teams.
Write and approve
investigation reports as delegated by complaint analysts for certain,
pre-determined complaint categories.
affiliates, verify product code/lot code information in AS400; conduct
complaint database searches as well as complete complaint closures.
appropriate functional departments to achieve effective corrective actions and
document within the complaint handling database.
supporting the quality processes associated with product complaint handling,
procedures, and controls to ensure that all complaints are processed in
accordance with established company procedures and worldwide regulations and
complaint related information to ensure appropriate Analysis, Investigation,
Root Cause, Technical, Clinical, and Quality Engineering Review, and any
appropriate actions are undertaken and documented.
Manufacturing Supervisor, 04/2006
to 04/2012 DePuy Synthes – Warsaw,
Ensured that work in the medical device industry
takes place as per guidelines and regulations
Ensure that all safety standards are met machinery
in the production house is safe and working optimally
Ensured that employees perform efficiently to
meet standards for department goals
Formulated guidelines and regulations for
better performance of employees
Act as a liaison between labor and upper
Overseen the raw materials procured, final
goods produced and finances involved within AS400 and SAP
Trained new employees in safe and high
Updated department KPI metrics
Conducted safety drills to prepare employees
for emergency situations
Conducted workshops in order to train workers
in better work methods
Ensured that the production targets of the
company are met
Presented monthly reports to managers and
relay any requirements
Assisted lean manufacturing manager and
Production Associate, 03/2001
to 04/2006 DePuy Synthes – Warsaw,
IN Production assoicate on manufacturing shop floor within the packaging and west side general departements.
Bachelor of Science: Management,
2016 Grace College - Winona Lake,
Associate of Science: Business Administration ,
2014 Indiana Tech - Fort Wayne,