I have a fantastic opporunity for a Quality Engineer to join a leading medical device company in Cork on a long term hourly rate contract with rates depending on experience.

Responsibilities

• Develop and implement quality assurance policies, procedures, and systems in compliance with regulatory requirements, Good Manufacturing Practices (GMP), and industry standards.
• Ensure that all manufacturing processes, testing, and documentation procedures are in compliance with established quality standards.
• Analyze data to identify trends and opportunities for process improvements.
• Investigate and resolve quality issues, deviations, and non-conformances.
• Conduct audits and inspections of internal processes and external suppliers to ensure compliance with quality standards.
• Collaborate with cross-functional teams to ensure products are developed, manufactured, and tested with quality in mind.
• Develop and provide training to employees in quality-related processes and regulatory requirements.
• Participate in the development and review of Standard Operating Procedures (SOPs) to ensure compliance with regulatory requirements.
• Maintain quality documentation and records, ensuring they are complete, accurate, and up-to-date.
• Stay up-to-date with changes
  
  

Education & Experience

• Strong knowledge of FDA regulations and GMP guidelines
• 3+ years experience in a Similar Role
• Attention to detail and accuracy
• Excellent communication and interpersonal skills
• Ability to think critically and problem-solve
• Strong organizational and time management skills
• Familiarity with quality control testing methods and techniques
• Proficiency in statistical analysis and data interpretation
• Technical writing skills for creating reports and documentation
• Understanding of risk management and safety protocols
• Knowledge of process improvement methodologies such as Six Sigma or Lean
  
  

For more information on the role please feel free to contact our specialist engineering recruiter Gerard Crowley by calling 021-2300-300

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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