Quality Engineer: QMS & Process Validation (Medical)

Matrix Recruitment Group

Longford

On-site

EUR 42,000 - 56,000

Full time

8 days ago
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Job summary

Matrix Recruitment Group seeks a Quality Engineer to join a well-established manufacturing team. You will report to the Quality Manager and support the quality management system and daily operations with your expertise to uphold product quality and compliance.

The role requires a third-level qualification in Engineering or Polymer Science and 3+ years in QA engineering within injection moulding or medical manufacturing, with strong analytical and communication skills.

Qualifications

  • Third-level qualification in Engineering, Polymer Science, or equivalent experience.
  • 3+ years in Quality Assurance Engineering within injection moulding or medical manufacturing.
  • Experience with statistical analysis, SPC, and validations.
  • Excellent communication, facilitation, and influencing skills.

Responsibilities

  • Develop and implement improvements for the quality management system (QMS).
  • Maintain compliance with ISO 13485 and ISO 14001 standards.
  • Liaise with customers on new products, quality concerns, and process qualifications.
  • Create and run process control programmes to meet customer needs.
  • Conduct process validations and product qualifications.
  • Offer quality engineering support for manufacturing issues and product disposition.
  • Analyse quality data to prevent non-conformances and minimise risk.
  • Coordinate NCR and CAPA processes for swift resolution of issues.
  • Deliver training on quality procedures including GMP, compliance, audit preparation, and GDP.
  • Support and represent the site during external/internal audits.
  • Track quality data to drive improvements.
  • Assist with Environmental, Health & Safety requirements.

Skills

Statistical analysis
SPC
Validations
Communication
Facilitation
Influencing skills

Education

Engineering or Polymer Science degree

Job description

Matrix Recruitment Group seeks a Quality Engineer to join a well-established manufacturing team. You will report to the Quality Manager and support the quality management system and daily operations with your expertise to uphold product quality and compliance.

The role requires a third-level qualification in Engineering or Polymer Science and 3+ years in QA engineering within injection moulding or medical manufacturing, with strong analytical and communication skills.

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