facebook twitter


Quality Systems Manager

Location: Galway
Reference no. : 1666
Date added: 06/03/2020
Salary: €Neg




Description

 

                              Quality Systems Manager

The Quality System Manager is responsible for managing the processes and people within the Quality Systems dept to ensure that the company is in compliance with all applicable regulatory and business requirements.

 

Job Responsibilities

  • Manage the Quality System team and ensure that both regulatory and business requirements are met in the daily running of the department. This includes motivation, training, and appraisal of QS staff.
  • Responsible for processes within Document Control training, Customer Quality, and Master Data area.
  • To take a leadership role in driving improvement initiatives in the Quality Management system across the site.
  • Drive and enhance a compliance culture though-out the site.
  • Providing Quality Systems support for all business units and sites.
  • Preparing for and supporting external audits (TUV, FDA, customer etc).
  • Ensure adequate monitoring and measurement of processes, and reporting the same to management.
  • Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organization.
  • Be responsible for Health & Safety within assigned areas.
  • Manage the plants quality system ensuring it's in agreement with all regulatory compliances.
  • Any other duties assigned from time to time.

Qualifications

  • Level 8 degree in Quality Assurance or Degree in Science / Engineering with an additional qualification in Quality Assurance.
  • Experienced Quality Systems Manager with a minimum of 3 years experience within the Medical Device or related industry.

 Key Requirements

  • Excellent working knowledge and proven track record in all aspects of ISO13485 and FDA QSR requirements.
  • Regulatory experience / knowledge.
  • Good organization, supervisory, technical writing and investigation skills are required.
  • Excellent communication and interpersonal skills.
  • Proven ability to influence.

Competencies

Building Effective Teams

Motivating Others

Managing and Measuring Work

Values: Integrity, Accountability,Teamwork, Innovation

SET : Strategy, Execution, Talent (for managers)

 

For further information, please call our offices on 093 41932 or e-mail your cv to Bernie at  bernie.dempsey@bdr.ie



Back

 

HR Manager

Environmental Health & Safety Officer

Injection Moulding Process Engineer- Europe

Injection Moulding Technican's - Europe

Safety & Design Quality Assurance Manager- UK

NPI Purchasing Manager UK Based

Senior Manufacturing Engineer - Needles

Quality Operations Manager

Principle Supplier Quality Engineer

Quality Engineers

NPI Manufacturing & Process Development Engineer

Injection Moulding Production Manager

IT Support Engineer - Galway (URGENT)

IT Support Technician- Munster

MANUFACTURING ENGINEER

Packaging & Labelling Engineer

Quality Systems Manager

Senior Quality Engineer

IT Support Specialist

Senior Product Development Engineer

Toolmakers

An experienced Printer required

NPI Purchasing Manager UK Based

Buyer -UK based