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ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned to meet business needs.

·         Accomplishes quality assurance objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.

·         Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.

·         Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.

·         Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.

·         Validates quality processes by establishing specifications and quality attributes; Documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.

·         Maintains and improves quality by completing compliance and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new procedure and process designs and training methods.

·         Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.

·         Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.


·         Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.


·         Tactical

o   Analyze current return process; build out short, mid and long term improvement plan

o   Work with business group to implement customer and vendor friendly returns process

o   Analyze return metrics and create root cause improve plan

o   Work with Supply Chain team to create and implement vendor vetting, correction action and quality measurement program

o   Work with customer team to create and implement a customer feedback/survey program


·         Metric’s

o   PartsSource RTN %

o   Vendor quality RTN %

o   Salvaged RTN %

o   Day Outstanding

o   Bad debit, write off $’s

o   Customer Survey

QUALIFICATION/REQUIREMENTS:  Process Improvement, Analyzing Information , Strategic Planning, Verbal Communication, Informing Others, Quality Management, Emphasizing Excellence, Attention to Detail, Thoroughness, Dealing with Complexity

  • Strong analytical skills and experience with implementation and administration of Quality Assurance metrics, such as defect profiles and performance to entry/exit criteria.
  • Excellent problem solving, interpersonal communication and project management skills a must.
  • Strong leadership skills that inspire team confidence and respect while motivating team members in a creative and effective manner.
  • Must have a desire for achieving excellence in customer satisfaction, process, quality and reliability.
  • Must have experience in managing and working with distributed team members.
  • Knowledge of internet and e-business processes, disciplines and standards.
  • Must be extremely detail-oriented with respect to documentation and communication.
  • Regulatory compliance/ medical device industry experience a plus.



  • BS/BA degree in computer science, engineering or related discipline.
  • Minimum of 7 years of quality assurance experience, to include a minimum of 3 years in a lead role or management position.

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