Design Assurance Manager

Job description

Design Assurance Manager

About Your New Employer

In your job as Design Assurance Manager, you will be working for a leading manufacturer of Medical Device's in Galway City. In your new job you will be working with devices used to save and enhance lives. 

About Your New Job

  • You will provide direction, management support and leadership to the Quality team.
  • Your job is to participate, support and provide independent review of all verification and validation activities.
  • As Design Assurance Manager, you will identify opportunities to improve organisational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products or increase customer satisfaction.
  • You will promote and support the business excellence program, leading by example. Partner with functional leaders to ensure that this program and the organisation values are at the forefront of decision making and action.
  • You will perform a variety of management related tasks to ensure that quality improvements are achieved as required.
  • It's your job to ensure compliance with GMP and GDP requirements for medical devices and medicinal products.
  • You will develop budgets for the Quality Department 

What You Need

  • A Degree in Engineering, Sciences or equivalent qualification.
  • Experience working in Design Assurance in the Medical Device industry. 
  • Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), JPAL/JGMP and Medicines Directive 2001/83/EC.

What's on Offer

In addition to all statutory entitlements and a meaningful job where you help save lives, you will get:

  • Fully covered Health Insurance 
  • Pension Scheme
  • Life Assurance
  • Educational Assistance 
  • Career Progression Opportunities

What’s Next

Apply for your new job now by clicking the apply button, or contact Dean Flynn at Sigmar Recruitment for more information T: +353 91 455306 E:

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