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Quality Engineer II

ID
15198
Location
Galway, Galway
Role Type
Contract

Quality Engineer II

Similar Jobs
Quality Engineer II

(6-month starter contract)

The Quality Engineer will be responsible for supporting manufacturing operations through effective change management, nonconformance and CAPA (Corrective and Preventive Action) processes, and line support activities. This role requires a strong understanding of regulatory requirements (e.g., FDA, ISO 13485, MDR) and their application in a production environment. The Quality Engineer will collaborate cross-functionally to ensure product quality, compliance, and continuous improvement, with additional responsibility for supporting validation activities (process, equipment, and test method validation).

Key Responsibilities

  • Lead and support change management and change control activities to ensure compliance with quality system requirements and regulatory standards.

  • Investigate and manage nonconformances and ensure timely closure of associated CAPAs, including root cause analysis, risk assessment, and effectiveness verification.

  • Provide line support for daily production issues, including disposition of nonconforming product, troubleshooting quality issues, and ensuring adherence to approved procedures.

  • Partner with manufacturing, engineering, and supply chain to drive continuous improvement initiatives while maintaining compliance.

  • Ensure implementation and compliance with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, EU MDR, etc.) within the production environment.

  • Support and review validation activities (equipment qualification, process validation, and test method validation), ensuring adherence to company and regulatory standards.

  • Author, review, and approve quality system documents including protocols, reports, procedures, and work instructions.

  • Act as a quality representative during audits and inspections, providing documentation and explanations as needed.

  • Analyze quality data (trends in nonconformances, CAPAs, complaints, etc.) and recommend improvements to prevent recurrence.

  • Promote a culture of quality, compliance, and continuous improvement across the site.


Required:

  • Bachelor’s degree in Engineering, Life Sciences, or related technical field.

  • 2–5 years of experience in a regulated medical device or similar industry.

  • Strong knowledge of CAPA, nonconformance, and change control processes.

  • Experience with FDA QSR, ISO 13485, and EU MDR requirements.

  • Experience supporting validation activities (process, equipment, or test method).

  • Excellent problem-solving, root cause analysis, and decision-making skills.

  • Strong communication and interpersonal skills with ability to influence cross-functional teams.

  • Detail-oriented with strong organizational skills and ability to manage multiple priorities.

Preferred:

  • Experience working directly in a manufacturing/production support role.

  • Green Belt/Black Belt certification or equivalent training in Lean/Six Sigma methodologies.

  • Prior experience in a similar role within Boston Scientific or another global medical device manufacturer.

Core Competencies:

  • Quality & Compliance mindset

  • Technical expertise and analytical thinking

  • Cross-functional collaboration

  • Problem-solving & root cause analysis

  • Communication & influence

  • Adaptability in a fast-paced production environment


Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters 

 For further information on this role please contact Geraldine Gormally on 0861071395  / recruit@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 your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

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