Job Detail

Location Limerick
Salary Negotiable
Posted
Role Type Permanent
Contact Clara Burke
email science@hero.ie

Senior Sterilisation Engineer

Job ID: JOB-11749
Senior Sterilisation Engineer

A leading medical device manufacturer in Limerick is recruiting for a Senior Sterilisation Specialist to join their team on a permanent basis. The primary purpose of this position is for the Management of the sterilisation programme.

Responsibilities:

  • Responsibility for the Management of the sterilisation programme including validation and re-validation of contract sterilisation.
  • Responsible for Sterilization related queries associated with internal and external audits
  • Performing product assessment against microbiology requirements in relevant standards.
  • Become part of the Global Sterilisation team and lead projects.
  • Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820.
  • Responsibility for completing appropriate sterilization requirements as part registration of the products in various markets.
  • Preparation, execution and analysis of related Quality documentation.
  • Ensure that the Code of Conduct is considered in all business matters carried out on the company’s behalf.

Qualifications / Requirements:

  • Third level Qualification in Microbiology with at least 5 years experience in a similar role (relevant experience in same with equivalent third level Science Qualification will be considered).
  • ETO Sterilisation experience is essential for this role.
  • A strong knowledge of biocompatibility is desirable.
  • Thorough knowledge and experience of a regulated industry, including GMP, GDP, GLP.
  • Knowledge of medical device quality standards/practises or similar regulated industry such as ISO10993, EN550, EN ISO 11135-1 and 11737-1.
  • Knowledge of regulatory requirements.
  • Good knowledge of CAPA, NCR and deviation process.
  • Good communication both written and verbal and good inter-personal skills.
  • Proven problem-solving skills.
  • Good computer skills including knowledge of Microsoft® Office.
  • Proven organisational skills.
  • High self-motivation and proven team member skills.
  • Willingness and availability to travel on company business.

For further information on this Senior Sterilisation Engineer role in Limerick please contact Clara Burke on 086 8168273 science@hero.ie 

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

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Clara Burke

JOB-11749

Senior Sterilisation Engineer

Clara Burke

Role Type Permanent
Contact Clara Burke
email science@hero.ie
mobile +353 86 816 82 73
linkedIn profile click here

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