Role Purpose
The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs.
Do
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Stakeholder Interaction
Stakeholder Type
Stakeholder Identification
Purpose of Interaction
Internal
Team Leaders
Performance review
HR
Hiring and employee engagement and retention
Training Team
Capability development
Technical Lead
Training, issue escalation/ resolution
External
Client
Query Resolution
Display
Lists the competencies required to perform this role effectively:
- Functional Competencies/ Skill
- Process Knowledge ? Knowledge of assigned process, tools and systems ? Foundation to Competent
Competency Levels
Foundation
Knowledgeable about the competency requirements. Demonstrates (in parts) frequently with minimal support and guidance.
Competent
Consistently demonstrates the full range of the competency without guidance. Extends the competency to difficult and unknown situations as well.
Expert
Applies the competency in all situations and is serves as a guide to others as well.
Master
Coaches others and builds organizational capability in the competency area. Serves as a key resource for that competency and is recognized within the entire organization.
- Behavioral Competencies
- Collaborative working
- Problem solving and decision making
- Attention to Detail
- Execution Excellence
- Client (Internal) Centricity
- Effective Communication
Deliver
No.
Performance Parameter
Measure
1.
Process
No. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback
2.
Self- Management
Productivity, efficiency, absenteeism, Training Hours, No of technical training completed
- Owns the complaint handling process including
- Complaint evaluation including adverse event reporting decisions, coding, follow up for additional information and closure of records
- Initiating Good Faith Effort (GFE) and Follow-ups for additional information and product returns
- Assessment of Complaints (events) for proposed MDR reportability and submits assessment to client and/or submits directly to the regulatory authority
- Owns the complaint investigation activities including:
- Assessment of the accuracy of the hazard code assigned to the record
- Run the decision tree based on the information available in the complaint record
- Reportability assessment
- Complete good faith effort for missing information (NR)
- Failure code assignments (NR)
- Risk Level Assignment( NR)
- Complaint Review and Closure
- Assesses cases to determine if event meets Philips' complaint criteria and escalates to Philips is required
- Performs reviews and assessments of complaints processed by peers as part of cross utilization approach
- Responsible for contacting SME's, QAs, Team Lead as needed to obtain complaint closure
- Responsible in timely escalation of significant events to the Team Lead
- Keeps oneself updated, aware of, and compliant to all Company and Customer policies and procedures which include Information Security Management Systems
- Keeps all company information which includes customer information confidential and secured
- Registered Nurse with License wit h minimum 0 - 1 years of experience
- Registered Nurse with License with 1+ years of experience in a medica l device or regulated industry preferred
- Has basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001
- Able to write effective Medical and Technical narratives regarding the complaints
- Able to create Customer Letters, if required
- Must have good computer skills, effective keyboarding skills
- Must have excellent telephonic and listening skills
- Able to think critically to determine the type of questions which need to be asked to gather necessary information
- Good problem solving and analytical skills
- Good customer service skills