Quality Assurance Specialist

7 days ago


Longford, Ireland Opto Recruitment Full time
Job Description

The Quality Assurance Specialist will be responsible for ensuring the successful functioning of our manufacturing facility by supporting all quality aspects.

  1. Qualifications and Experience:
  2. A third-level qualification in engineering, polymer science, or equivalent manufacturing experience is required.
  3. Experience in statistical analysis (Minitab), SPC, and validations is essential.
  4. Excellent interpersonal, communication, influencing, and facilitation skills are necessary.
  5. A minimum of 3 years' experience as a Quality Assurance Engineer within an injection moulding or medical manufacturing environment is required.

Duties and Responsibilities:

  1. Sustain and Improve QMS: Develop and implement solutions to sustain and improve the QMS.
  2. Compliance: Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
  3. Customer Interface: Interface with customers on new products, quality issues, and process qualifications.
  4. Process Control: Develop and implement process control programs to ensure customer requirements are met.
  5. Process Validations: Carry out process validations and qualification on products.
  6. Manufacturing Support: Provide manufacturing support and quality expertise in relation to manufacturing issues and product disposition.
  7. Quality Engineering Analysis: Perform quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
  8. NCR/CAPA Process: Coordinate NCR/CAPA process to ensure timely resolution and closure of issues.
  9. Training: Lead training activities on quality procedures, e.g., compliance, GMP, audit prep, and GDP.
  10. Site Representation: Support and represent the site during external audits and carry out internal audits.
  11. Quality Data Analysis: Trend and track quality data to support quality improvements across the business.
  12. EHS Requirements: Support environmental, health, and safety requirements, training, and regulations.


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