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

and procedures.

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.

Minimum Education.

Bachelor's degree in Life Sciences, Engineering or similar field or an equivalent combination of education plus

work experience.

Qualifications

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.

Primary Location

Ireland-Dublin-Dublin

Organization

AMO Ireland (7253)

Job Function

Quality Assurance

Requisition ID

00001BLV