Key Responsibilities:

• Ensure compliance with applicable regulations, industry standards, and internal quality system requirements.
• Lead or support root cause analysis and implementation of effective corrective/preventive actions (CAPA).
• Support risk management activities, including Failure Mode and Effects Analysis (FMEA) and risk assessments.
• Collaborate with R&D, Manufacturing, and Supply Chain to ensure product quality throughout the lifecycle.
• Participate in product and process validations, including protocol development, execution, and report writing.
• Review and approve quality documentation such as change orders, validations, deviations, and non-conformances.
• Monitor and analyze quality metrics to identify trends and recommend process improvements.
• Support internal audits, supplier audits, and regulatory inspections.
• Provide training and guidance on quality system requirements to cross-functional teams.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.

Qualifications:

Education: Bachelor’s degree in Engineering, Science, or a related technical field.

Experience:

2–5 years of experience in quality engineering, regulatory compliance, or a related discipline (preferably in medical device, pharmaceutical, or other regulated industries).

Experience with quality systems such as ISO 13485, FDA 21 CFR Part 820, or similar standards.

Skills & Knowledge:

• Strong knowledge of root cause analysis, CAPA, and problem-solving methodologies.
• Familiarity with statistical methods, process capability, and data analysis tools.
• Experience with validation (IQ, OQ, PQ), risk management, and document control.
• Proficiency in quality management systems (QMS) and electronic documentation tools.
• Excellent communication, collaboration, and technical writing skills.
• Strong organizational and time management abilities.

Preferred Qualifications:

• Certification in quality (CQE, CQA, Six Sigma Green/Black Belt).
• Experience in medical device, pharmaceutical, or life sciences manufacturing.
• Knowledge of supplier quality management practices.
• Familiarity with lean manufacturing and continuous improvement methodologies.

Competencies:

• Analytical and detail-oriented mindset.
• Ability to influence cross-functional teams without direct authority.
• Strong problem-solving and decision-making skills.
• Adaptability in a fast-paced, regulated environment.
• Commitment to quality, compliance, and customer satisfaction

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.