Head,Quality Surveillance Customer Affairs Systems Metrics & Tech Aff.
•Provide business program ownership, including system support, trending and metrics development, to ensure activities conducted for Alcon medical device complaint handling, Medical Product Information and customer resolution/response related to complaints are in compliance with all regulations, guidelines, directives and standards established by the relevant regulatory agencies and Novartis.
- Support activities to maximize standardization and compliance while designing, documenting and refining process work flows for efficiencies and concurrently managing/providing solutions to the business.
- Lead key start-up activities required for strategic planning of the Product Quality Surveillance and Customer Affairs (PQSCA) systems supporting Complaint Handling, Medical Product Information and Complaint Resolution (response to customer).
- Coordinate, define and monitor the PQSCA System Metrics and Trending Processes.
- Provide tools for PQSCA Management to oversee and maintain business process implementation.
- Provide direction and guidance regarding the impacts of data standards and data quality.
- Collaborate with PQSCA management to identify process/data gaps, redundancies, and inaccuracies and prepare process improvement solutions to address.
- Support the investigation of quality events (i.e., deviations) detected; provide support to the medical safety team and relevant functions on proper identification and escalation of quality related issues; ensure issues are appropriately escalated as per Novartis Quality Manual.
- Identify and resolve process related issues, creating alternative process proposals for efficiencies.
- Drives continuous improvement projects (as relevant) in an effort to maximize standardization, productivity and compliance within PQSCA.
- Provide guidance to PQSCA personnel, as required, to identify, avert and/or resolve technical problems.
- Actively participate in Quality Management Reviews to assess the continued suitability, adequacy, and effectiveness of the quality system throughout the product life cycle.
- Review and monitor data across functional areas to ensure consistency and application of data standards and data quality.
- Analyze and monitor key complaint handling processes ensuring end-to-end customer focus from intake to closure and customer response.
- Collaborate with PQSCA management to develop and implement accurate and effective reports associated with complaint handling, customer response and Medical Product Information.
- Manage trending of technical quality complaints and preparation of signal detection reports for timely identification of quality issues.
- Interact with R&D QA to provide timely feedback of product quality issues with potential for design related improvements
- Manage trending of customer responses/interactions to drive consistent and timely feedback efforts.
- Generate accurate PQSCA data outputs.
- Manage complaint handling and MPI business support globally, including regional and affiliate levels.
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information
alrpo EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Bachelor’s degree in a life science or medical related field.
- Fluent in written and spoken English. Additional languages preferred.
- 7+ years QA work experience in a regulated medical device/Pharmaceutical industry
- 3 years leading people
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