J&J Family of Companies Supervisor OUS Product Safety- J&J Vision Dublin in Dublin, Ireland
Primary Job Function
Responsible for managing the quality processes related to AMO post-market product complaints, reporting on
trends, driving corrective actions and ensuring compliance to all applicable Corporate and Divisional policies
Demonstrates thorough understanding of quality management standards as outlined in Good
Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs) and ISO 13485.
Drives departmental process improvements to effectively communicate knowledge, both within the department and
throughout the organization to contribute to overall success of AMO.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Manages and coordinates activities of employees engaged in the complaint handling and adverse event
reporting process. In addition, may be required at times to complete these tasks. May manage both Non
Exempt and Exempt associates.
In addition to supervising complaint handling, provide Quality Assurance leadership with product quality data
and complaint trending to drive product improvements and Corrective and Preventive Actions. In conjunction
with Corporate QA, assists in field actions (including product recalls) as required. Prepare or assist department
leadership with monthly trending reports, annual post-market surveillance reports and other monthly and
quarterly reports. Participate in various process improvement projects. Responsibilities include interviewing,
hiring, and training employees; planning, assigning, and directing work; appraising and managing performance;
addressing complaints and resolving problems.
Exercises authority and judgement to determine appropriate action. Recognizes that failure to achieve results or
erroneous decisions or recommendations may result in significant non-compliance issues.
Supervisory / Management Responsibilities
Direct Reports circa 5
Position Accountability / Scope
Enhance and strengthen Product Safety's partnership with other key organizations within the company such as
R&D, Technical Service, Customer Service and Clinical Support to improve the quality and capture rate of
customer inputs regarding AMO products. Cultivates a wide range of internal networks and develops an
external network of resources to facilitate completion of tasks. Plans, organizes, and prioritizes group's daily
work routine to meet established schedule.
The position is accountable for:
timely and accurate product complaint entry, reporting, customer communication and complaint closure.
optimizing complaint cycle time while maintaining compliance to all regulations.
compliance with all FDA regulations governing complaints and MDRs.
Bachelor's degree in Life Sciences, Engineering or similar field or an equivalent combination of education plus
Minimum Experience / Training Required
4-6+ years in medical device and/or pharmaceutical industry in quality and compliance
One to three years of supervisory experience
experience with complaint handling for medical products
Strong people management skills
Excellent verbal and written communication skills, Excellent trainer of QS/complaint handling elements
Past experience with Notified Bodies/FDA and ability to interact appropriately and authoritatively during the
course of a facility level inspection
- Thorough knowledge of FDA/GMP/ISO requirements and regulations, with particular emphasis on complaint
handling and adverse event reporting
- ability to work well in a team environment.
AMO Ireland (7253)