Primary Job Function
Identify, analyze, investigate, monitor and document patterns and trends in post marketing surveillance data as part of the CAPA system.Analyze and investigate product complaints from the field as part of
post marketsurveillance requirements.Communicate and educate management, R&D, marketing, sales
organization andother departments, as well as external customers about product performance. Ensure
that information and insight gained from the investigations and corrective actions is fed back to the R&D
and marketing organizations as part of the risk management and design input systems. Develop Post
Market SurveillancePlans and provide engineering support for complaint investigation readiness of new
Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1.Analyzes customer complaints, events and other post marketing surveillance data by examining the
data forpatterns and trends and investigating when necessary.;
2. Investigates customer complaints related to productquality or patient safety.;
3. Investigates identified trends by starting a formal trend investigation and trendreport and working on
4. Documents trend action by updating the trend report atappropriate levels and by performing
a Health Risk Analysis.;
5. Communicates product performance by formalpresentations to management committees and design teams, supporting published product performancereports and supporting customer requests for performance information either directly or through the sales organization.;
6. Provides input for process improvement and helps develops tactical approaches to implementteam strategies.;
7. Develop test plans, procedures, justifications papers and provide engineering support fornew product complaint readiness.
(Supervision Received) Works under only general direction. Independently determines and develops
approachto solutions. Work is reviewed upon completionfor adequacy in meeting objectives.;
(Supervision Provided)May provide work direction and guidance to exempt and/or skilled nonexempt levels of employees; may
beasked to evaluate performance of and assist in careerdevelopment planning for subordinates.
Position Accountability / Scope (Influence/Leadership) Establishes and cultivates an extensive network of support to facilitate completion ofassignments. Participates in the developmentof less experienced staff by setting an example,
providingguidance and work direction, and offering counsel. May lead a project team. Participates
in determining goalsand objectives for projects. Influences middle management on technical or
business solutions. May interactwith vendors.;
(Planning/Organization) Plans and organizes non-routine tasks w/approval. Initiates or maintains work
schedule. Establishes priorities of work assignments.;
(Decision Making/Impact) Exercisesjudgment in selecting innovative, practical methods to achieve problemresolution. Failure to obtain results orerroneous decisions orrecommendations would typically result in serious program delays and considerableexpenditure of resources.
Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functionalarea, or an equivalent combination of education and work experience. Advanced degree preferred.