The purpose of the role is to assist in the execution of complaint handling and investigation operations in India related to complaints received on Alcon medical device products, not limited to oversight of investigation activities, generating complaint summaries and follow up interactions with external Alcon customers to provide direct feedback. 

Be a change agent instilling a quality culture and mind set through a robust Quality Management System, providing the basis to work collaboratively with all internal and external customers including MTO, R&D, Medical Safety, Compliance, Sales, Marketing, Customer Service, Field Service Engineers (FSEs), Medical Science Liaisons (MSLs), Clinical Applications Specialists (CASs) and Alcon external customers (Surgeons, Ophthalmologists, etc.).

Support the organization in maintaining a compliant and efficient Complaint Handling system that includes ensuring accurate, timely and thorough investigations/summaries, and effective customer interactions, feedback and issue solving.

• Ensure India processes and guidelines are developed and maintained to comply with regulations, guidelines, and directives for complaint handling operations.

• Ensure the Complaint Process is end-to-end customer focused, including technical evaluation / investigation of global complaints and providing timely and accurate feedback to internal and external customers.

• Responsible for oversight of platform specific global technical complaint investigation activities, including follow up activities with relevant internal departments (MTO facilities, Medical Safety, FSEs, CASs, and R&D) and ensure timely resolution to investigations.

• Compile and summarize all investigation activities received from internal customers and deliver appropriate written, verbal or in person communication back to external customer, when appropriate.

• Review investigation summaries involving complaints from external customers to coordinate and direct interactions with these customers to discuss and provide appropriate feedback on completed investigations related to reported complaints.  Involve FSEs, MSLs, CASs, Commercial, etc., as appropriate.

• Attend major industry scientific meetings as needed to interface with external customers, including attendance at KOL meetings, and to gather related competitive intelligence.

• Provide appropriate external customer feedback to R&D, MTO, Commercial, etc. teams to evaluate complaint related issues with Alcon products.

• Interface with Customer Service to ensure received complaints are handled compliantly per procedure

• Attend FSE, CAS, and Sales trainings as appropriate for visibility into related activities.  Educate these functions on responsibilities of Quality Customer and Technical Affairs.

• Milestones and outcomes

• Individual project completion

• Customer Feedback

Number of Associates:  Indirect oversight of quality investigators in manufacturing plants

Minimum education: R.N., O.D., M.D., or equivalent

Alternatively, 15+ years in Alcon R&D, Reg Affairs, etc with knowledge of Alcon technical product information

English fluently spoken & written

• At least 5 years of experience in Quality Assurance, Medical Affairs and/or R&D, including customer interfacing positions in the Medical Device industry

• At least 5 years of experience in a medical device clinical setting

• Proven successful performance in a global/matrix environment.

• Proven capability to get results through people and influence across boundaries

• Experience with external health authorities

• Customer focus

• Problem Solving

• Strategic Agility

• Process Management 

• Communication

• Strong leadership experience

• Strong interpersonal, communication, negotiation and problem solving skills

• Strong Business awareness

• Successful experience working cross-functionally, in matrix organizations  and in global teams

• Strong “Collaborative Team player”

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