Regional Director of Quality Operations

This innovator is a global leader in medical device development and manufacturing services to the worlds’ primary healthcare and pharmaceutical companies in the Americas, Europe and Asia. Located in Leinster, this healthcare leader is the European Centre of Excellence for the development of medical devices including delivery of proof of concept, initial prototyping, clinical trial support, validation leading to full manufacturing of medical devices for global markets. With more than 40 years of experience, this businesses highly-specialised teams meet the complex demands of the diagnostic, medical device, pharmaceutical and consumer health markets, enabling the world’s leading brands to fulfill their market potential.

The Position:

  • Quality Management – designing and implementing Quality systems which comply with Corporate and/or BU Policies, training staff and key personnel in order to attain strategic objectives, along with providing management quality trend information to aid in achieving these objectives
  • Quality Assurance – establishing documentation required for the implementation and maintenance of an ISO certified quality system (ISO 13485) and compliance to applicable regulations and standards (e.g. 21 CFR 820, EEC/93/42, CMDR)
  • Inspection / Metrology – providing testing, measuring and calibration service for all instrumentation used within the locations for the execution of quality control plans
  • Design Assurance – executing transfer from development stages into production, including validation of manufacturing processes, equipment, and procedures required for the production and delivery
  • Product Surveillance – executing all product complaint investigations, as well as returns
  • Quality Control – provide systems that will ensure the efficient and effective inspection monitoring of production processes as well as initiating and directing corrective actions to problems relating to product or process quality, such as complaint resolution, customer interface, regulatory action
  • Quality Audit – Providing liaison between the operations management and auditing organisations (1st, 2nd, 3rd parties) as well as coordinating appropriate actions in response to findings
  • Procurement Quality – establishing and maintaining appropriate methods and monitoring necessary to ensure that purchased materials meet pre-established standards for usage
  • Talent Management – managing and developing all QA Site Leaders as well as overseeing talent management within the Quality function in order to maintain a strong bench strength for succession planning

The Person:

  • BA/BS degree required, preferably in engineering, science or clinical field
  • Professional certifications (CQM/OA, CQE, CQA, CSSBB) preferred
  • 10 years of experience (or equivalent) with regulatory in the drug and/or device industry within a Quality remit ideally leading a Quality function.

To learn more apply on line or call Shane Browne at HRM on +353 1 6321865.

Salary: On Application Location: Wicklow