Engineering Compliance Specialist

2 weeks ago


Athlone, County Westmeath, Ireland HERO Recruitment Full time
Job Description:

We are seeking a highly skilled and experienced Quality Systems Engineer to join our team at HERO Recruitment.

Main Responsibilities:
  • Represent the Quality function in site management meetings as required.
  • Provide guidance and support to the Quality Lead as needed.
  • Develop and implement process improvements, projects, and cost-saving initiatives using data and quality tools.
  • Initiate project plans, allocate resources, and guide technical activities such as risk documentation and process validation.
  • Lead investigations and provide technical guidance on software validation, CAPAs, NCs, and compliance issues.
  • Implement robust solutions and lead cross-functional teams to achieve project objectives.
  • Ensure adherence to regulatory requirements by assessing and providing guidance to Quality and Engineering disciplines.
  • Perform and lead internal and supplier audits, facilitating external regulatory body audits.
Requirements:
  • Bachelor's Degree or higher in Engineering or Science related field (minimum level 8).
  • At least five years' experience working in regulated environments, preferably in medical device, FDA, or ISO 13485 registered work environments.
Preferred Skills:
  • Lead Auditor or Internal Auditor certification an advantage.
  • Experience with JIRA, Qtest, and VERA for documenting software lifecycle is beneficial but not essential.
  • Familiarity with Oracle, FactoryTalk applications, PEMAC, and Bartender is advantageous.
Work Arrangements:

This role is eligible for hybrid working arrangements, allowing for some remote work, but requiring on-site presence 2-3 days per week.

Job Type:

Full-time.

 



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