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

 

Senior Moulding Engineer

MANUFACTURING ENGINEER

Design Assurance Engineer

Packaging & Labelling Engineer

Design Assurance Engineer

Care Co-ordinator/ Administrator

Quality Systems Manager

Program Manager - contract

Environmental & Health & Safety Officer

Marketing Coordinator

Senior Network Engineer, EMEA Region

Regional Buyer

Credit and Collections Analyst

Senior Credit Analyst

General Ledger Accountant

Senior Manager Oracle Financials

Senior MDM Developer Architect

Service/Logistics Coordinator

Customer Service with Languages

Project Engineer

Senior Quality Engineer

Design Assurance Engineer

Product Manager

Part Qualified Accountant

Production Manager

Head of Production

IT Support Specialist

Electrical Engineer

Senior Manufacturing Engineer

Global Senior R&D Manager

Customer Service Rep - German

Customer Service Rep

Regional Buyer

Production Control Manager

Production Control Scheduler

Procurement Manager

HSE Manager

Medical Pharmacovigilance Officer

Maintenance Technician

E-Marketing Specialist

Accounts Assistant

Junior Cost Accountant

The IT Executive Administration Assistant

Trade Analyst

Operations Solutions– Software Engineer

Senior Product Development Engineer

Senior Metrology Engineer

Toolmakers

Quality Manager

Marketing Communications Manager

Junior Financial Analyst

.NET Developer

Customer Service Rep

Quantity Surveyor

Chef's

Customer Experience Specialist

Senior Buyer

Customer Service Order Fulfilment Rep.

An experienced Printer required

Commodity Manager – Electronics

Finance Director

Engineering Director

Lead Estimator (Water/Wastewater)

Regional Logistics Manager (EMEA)

Project Manager, Service Delivery (EMEA)

Production Planner

Senior QA Compliance

Production Line Leader

Graduate level - Quality Control Analyst

Production Line Leader

Junior QA Inspector

Quality Control Analyst

Laboratory Quality Manager

Laboratory Engineer

Bids and Proposals Director

PRODUCTION SCHEDULER

Production Control Analyst

Manufacturing Engineering Technician

Manufacturing Engineer

Sales Support Rep-Polish,Russian,Romanian Speaking

Senior Financial Analyst

Manufacturing Technician - Urgent

Senior Equipment Development Engineer

Manufacturing/Process Engineer

Engineering Outsourcing Manager

Software Project Manager

LEAN SPECIALIST

Telesales Repersentative - French

Inside Sales Representative- English & F

Infrastructure Systems Engineer

General Counsel/Legal Officer

Accounts Payable Specialist with French

Maintenance Manager

Plant Accountant – Maternity cover

Quality Engineer - Graduate Entry Level

Program Director

Account Payable Analyst

Manufacturing Engineer/ Junior Project Manager

Supply Chain Director

Technical Architect

Technical Project Manager

Junior Office Administrator - Urgent

Technical Project Manager

Health, Safety & Environment Manager

Purchasing Team Lead

IT Support Analyst

Plant Supply Chain Manager

Client Care Manager

Business Analyst

Sales Executive

Junior Technical Support Agent

Global Supply Chain Project Manager

Accountant

Junior Financial Accountant

Site HR Director

Production Supervisors

Production Supervisors

Supply Chain Scheduler

CAD and Project Engineer

Senior Aerospace Engineer

Maintenance Technician - Urgent

Systems Function Lead

Systems Engineer

Supply Chain/Continuous Improvement Supervisor

Software & Systems Operations Manager

Quality Assurance Engineer – UK

Procurement Team Leader UK Based

Trade Compliance Manager – UK Based

SYSTEM ARCHITECT

PRODUCTIVITY BUYER

MECHANICAL DESIGN ENGINEER

Senior Buyer

R&D Engineer – System Design Architect

Test Lab Engineering Technician

Computer Vision Software Project Lead

IMAGE QUALITY ENGINEER

TEST DEVELOPMENT ENGINEER

ADAS SIMULATION ENGINEER

Sales, Inventory & Operations Planning Manager- UK

Supplier Quality Assurance Engineer -UK based

Talent Development Specialist

Health &Safety Environment Site Manager

Product Support Lead

Process Development Engineer

Principal Engineer – Electronics UK

Principal Engineer – Electronics UK

Senior Buyer (NPI)

P1 Test Engineer

System Engineering Manager

Buyer

Senior Specialist Engineer – Electronics

DSP Embedded Software Engineer

Principal Engineer – Electronics

R&D System Test Lead

Systems Architect

Software Project Leader

Computer Vision Function Lead

R&D System Test Lead

Software Quality Engineer

Image Quality Engineer

Functional Safety Engineer

Test Engineer

Project Manager

Quality (Production) Engineer

Warranty Analysis Engineer

Embedded software engineer

Test engineer

R&D project team manager

Vision Feature Development & Application Engineer

Hardware design engineer - URGENT

Software architect

Embedded DSP engineer