Chief Quality Compliance Officer

4 days ago

Galway, Galway, Ireland beBeeDesign Full time €90,000 - €120,000
Job Description">

Senior Design Assurance Expert

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The successful candidate will serve as the Quality Assurance technical and compliance expert, working within a cross-functional team to support design and development of medical devices.

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Key responsibilities include:

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  • ">
  • Quality-related activities including risk assessments, device testing, internal and external audits, generation and approval of technical documents, and management of Design History Files (DHF).">
  • Continuous improvement of the Quality Management System (QMS)">
  • Ensure compliance of product development and risk management activities with governing regulatory requirements.">
  • Collaborate with product development teams to translate user needs into design requirements.">
  • Execute design verification, validation, and test method validation activities.">
  • Partner with R&D and Manufacturing Engineering to translate design requirements into manufacturing specifications.">
  • Lead resolution of project issues by applying structured problem-solving methodologies.">
  • Represent the organization professionally to external agencies, vendors, and regulators.">
  • Lead and/or support compliance and improvement initiatives within the QMS.">
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Required Skills & Qualifications">

A bachelor's degree in Engineering, Science, or related technical discipline.

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Minimum of 6 years' experience in Quality Assurance, Quality Systems, or Regulatory Affairs within the medical device industry.

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In-depth knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, EU MDR, Canadian Medical Device Regulations, and other international standards.

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Strong problem-solving, decision-making, and analytical skills.

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Excellent interpersonal skills with the ability to influence and collaborate effectively across teams.

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Strong written and verbal communication skills, with fluency in English.

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Benefits">

This is an opportunity to lead quality and compliance activities in medical device design, directly influencing the safety, reliability, and market success of life-changing technologies.

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Others">

Attractive compensation package, professional growth opportunities, and a dynamic work environment.

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