Return to jobs

Job Details

Similar Jobs

Senior Quality Engineer

ID
14495
Location
Galway
Role Type
Permanent
Contact
Mark Wilson
Email
talent@hero.ie
Phone
+353 86 0449473
LinkedIn
click here

Recruitment Consultant

Photo of Mark

Senior Quality Engineer

Similar Jobs

Senior Quality Engineer

Our Client, a leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets are seeking a Senior Quality Engineer to join their team on an initial 12 month contract.

 Job Overview:

The Senior Quality Engineer is a vital role aboard their Quality Assurance team to help drive process improvement initiatives and streamlining efforts of quality management systems. You can expect to be hands on supporting product development teams with design transfer activities, managing, and closing out CAPAs, and ensuring quality compliance for a diverse product portfolio.


Key Responsibilities:

  • Support of Clean Room (Class 8) procedures and controls and Environmental Monitoring
  • Co-ordination of Sterilisation programme for sterile products (including Dose audit program)
  • Provides support to product development and sustaining teams including but not limited to design input/output, verification/validation, risk management, and design transfer activities
  • Drives streamlining improvement initiatives in the Quality Management system across the site
  • Ensures quality system compliance to ISO13485, 21CFR 820, MDSAP and Medical Device Regulations
  •  Prepares metrics in support of trending and management reviews
  •  Provides quality inputs in product design updates and support design maintenance releases
  • Conducts internal audits when needed and serves as Quality System support for Regulatory and Corporate Audits
  • Takes ownership of managing and closing out CAPAs where required.
  • Guides product transfer activities and streamlining of quality management systems
  • Stays up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers

Key Requirements

  •  Third level degree in science e.g. Biopharmaceutical Science /Microbiology/ Chemistry or similar
  •  4-6 years of experience in Microbiology or Quality Assurance in the medical device industry.
  • Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
  • Strong CAPA experience
  • Experience of sterile products in a medical device or pharmaceuticals

 Here’s what you can expect:

  •  A competitive salary package
  •  Bonus scheme
  •  Defined Contribution pension plan
  •  Comprehensive Healthcare & Life Assurance coverage
  •  Additional benefits such as income protection and death in service-service benefit.
  •  Health & Wellbeing Events
  •  Recognition Scheme
  •  Free parking
  •  Educational assistance

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

 

Share Jobs

Search Jobs

Match my CV

We take the hard work out of finding you a new job. Simply upload your CV (or call us) and we’ll get hunting for you!