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Complaint Intake Senior Manager (Medical devices)

Description:

Responsibilities and Duties

 Develop and lead a high performing Technical Services teams that delivers an excellent service to both our internal and external customers Responsible for the Performance management of the Technical Services team, ensuring that the ‘CAN DO’ process is maintained, SMART goals are set and that team members receive relevant and timely feedback on an ongoing basis

 Develop and execute on clear strategies to deliver a measurably improved customer experience

 Develop and execute on clear strategies to deliver measurable operational efficiencies, eliminate and manage costs and budgets effectively

 Develop and maintain written policies and procedures around complaint handling and regulatory reporting per the ARDx global QMS as well as US and European (as well as other geographies where ARDx product is sold) to ensure thorough, consistent and timely documentation and routing of complaint information

 Provide Subject Matter Expert support for internal and external audits of the Technical Services and Complaint Intake functions

 Interface with legal manufacturer, vendors and field service providers re: case investigations and on-site service calls, acting to ensure appropriate and timely responses concerning product and customer service issues.

 Monitor and evaluate case documentation for case management to ensure quality documentation and to provide performance feedback.

 Represent site interests on global Technical Service and Complaint Intake teams, assisting in the development and implementation of short and long-term strategies.

 Establish KPI’s and reporting for APAC TS that delivers clear data on the performance of the Regional Technical Services teams and actions that need to be taken to measurably improve our customers experience

 Develop and implement systems to communicate meaningful product failure information and problem resolution records, which are available to all relevant teams

 Define & implement Technical Services development plan to move from transactional tasks, non added value tasks to added value services for our customers

 Best practice sharing with colleagues to increase knowledge and drive higher performance within the Technical Services team

 Accountable for report writing and data analysis to inform business discussions on opportunities for customer experience improvements and/or operational efficiency opportunities

 Day to day support and management of the regional Technical Services teams keeping the APAC Commercial teams, site Management team and the Global Director of Post-Market Surveillance informed as necessary (matrix management)

 Organising the workload for the team and ensuring that the right resources are available and trained to the highest standard

 Reviewing continuously opportunities to streamline processes and implement IT/SFDC that will drive efficiencies and improve our customer’s experience

 Keep appropriate records of all training activities and ensure such records meet and exceed any audit requirements/standards

 Maintain an up-to-date knowledge of Company products and industry in the areas of design, application, operation, troubleshooting, repair and maintenance

 Carry out duties in compliance with established business policies.

 Demonstrate commitment to the development, implementation and effectiveness of ARDx Quality

Management System per ISO, FDA, and other regulatory agencies.

 Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

 Perform other duties & projects as assigned.



Requirements:

Requirements / Qualifications:

Minimum of 5-8 years of experience in handling medical devices

Expert knowledge of medical device / diagnostics post-market surveillance regulations (e.g. US FDA 21 CFR Part 803 / 820, ISO 13485, Meddev)

 His / her current company has a complaint system

 He / she must have an experience in handling complaint process

 His / her company has CAPA (Corrective and Preventive action)

 He / she must have an experience in handling CAPA

 Able to travel internationally (approximately 5 to 10% annually)

 Must have an excellent communication skills

 Multi-lingual capability would be an advantage but cultural sensitivity is a necessity

 Expert knowledge of diagnostics on clinical and technical level.

 Exceptional service orientation and focus, experience in customer service methods and techniques.

 Advanced knowledge of systems with software and hardware components

Salary: ₱100000 - ₱180000
Address: Taguig city