Medical Devices JobsQuality Systems Engineer (Galway – Perm Role)

  • GY51286
  • Permanent
  • Galway

Collins McNicholas

A medical device SME is looking to hire an experienced Quality System Engineer in Galway to establish and maintain effective quality system structures to ensure consistent implementation of quality systems in the organisation.  

Key Duties

  • A leader and expert in the areas of quality systems, applicable medical device ISO standards, including ISO13485:2016 & ISO14971:2007 and Medical Device Regulations
  • Constantly promotes awareness of best industry practices making appropriate decisions on a daily basis.
  • Champions continuous improvement from a quality system perspective and educates functional areas on quality system requirements.
  • Implementation of internal requirements and external laws, regulations, guidance’s and standards, as applicable to the company’s quality systems.
  • Under the direction of the Senior Quality Manager, you will lead and manage the alignment of the QMS to the requirements of ISO13485:2016 & 21CFR820.
  • Participate cross-functionally and across the business to standardize and continually improve the Quality System policies and procedures.
  • Support Regulatory Inspections and Notified Body audits.
  • Responsible for compiling Management Review data, Quality metrics and driving continuous improvements in the quality system.
  • Responsible for the Internal Audit process, CAPA & non-conformance processes and Complaints process within the organization.
  • Conducting internal audits to schedule and maintaining/supporting the supplier quality management process.

Skills, Qualifications & Experience

  • Ideally will possess Degree/Post-Grad in Quality Management
  • 5+ years’ experience in a medical device manufacturing environment with direct experience in a Quality Systems role and with exposure to FDA / ISO13485 / CE Registration Process.
  • Experience with involvement in Regulatory submissions would be an advantage.
  • Experience with involvement in design/process validations and FMEAs would be a distinct advantage.
  • Lead Auditor or Internal Auditor certification an advantage.
  • Excellent interpersonal and communication skills.
  • Experience / training in a problem-solving and clinical environment considered a plus.

What you will get in return

  • Competitive salary plus a bonus and healthcare scheme
  • Fantastic opportunity to work in a growing business

Please get in touch to find out more information

elaine.dolan@collinsmcnicholas.ie

091 706 718

First Name

Surname

Your Email (required)

Your mobile (required)

Comment / Cover Letter

Upload CV

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Lean into fear! What are you afraid of?

Nicola Wash Galway Blog
We all see the motivational messages on social media – “be your best self”, “lean into fear”, “push yourself outside of your comfort zone” – and for a brief minute we vow to. But something stops us – fear. There’s the fear of going for it – of making a change. Fear of failure, of […]
Read More
  • Find a job
  • Apply
  • Get a job