Senior Quality Engineer (Projects)

March 19, 2025
Reference key: es13128_2
Permanent
Deadline date:

Job Description

  • Negotiable
  • Permanent
  • Clare

Senior Quality Engineer (Projects) – MedTech Leader (Co. Clare)

A leading MedTech multinational in Co. Clare is seeking a Senior Quality Engineer (Projects) to lead Quality Engineering support and drive continuous improvements while ensuring ISO 13485 & FDA QSR compliance. Reporting to the Senior Quality Manager, you will have overall responsibility for GMP standards and regulatory compliance within the manufacturing area.

Key Responsibilities

  • Lead & Mentor – Provide strong leadership within the Quality Engineering Team.
  • Drive Process Improvement – Support process development & manufacturing by analyzing trends, identifying root causes and implementing corrective actions (CAPA & NCs).
  • Quality Control & Risk Management – Utilize tools like SPC, Cpk, Ppk to maintain high product quality.
  • Regulatory Compliance – Ensure adherence to ISO 13485, FDA QSR, MDR 2017/745 and GMP standards.
  • Inspection & Validation – Define inspection plans, test methods, and validation for incoming materials and processes.
  • Resource Development – Train, mentor, and manage Quality Engineering support staff.
  • Verification & Validation (V&V) – Oversee product & process validation for new and existing assets.
  • Statistical Oversight – Ensure best practices in sampling plans, data analysis and reporting.
  • Stakeholder Communication – Effectively engage with suppliers, customers and regulatory bodies.

What You Need to Succeed

  • BSc/BEng in Engineering, Science, or related field (Postgrad in Quality Assurance is a plus).
  • 8+ years’ experience in Quality Engineering (MedTech or Pharma industry).
  • Certified Lean Six Sigma Green Belt (or equivalent).
  • Deep knowledge of ISO 13485, FDA QSR, MDR 2017/745.
  • Strong leadership & problem-solving skills with a proactive mindset.
  • Excellent communication & organizational skills with a keen attention to detail.
  • Proficiency in technical documentation – ability to write clear, concise protocols & reports.
  • Ability to work independently while collaborating within cross-functional teams.

Why Join?

Work with a global leader in MedTech innovation.
Career advancement in a high-growth, regulated industry.
Lead critical quality initiatives impacting global healthcare.
Collaborative, innovation-driven culture with professional development opportunities.

Ready to drive quality excellence? Apply now!