Senior Supplier Quality Engineer

March 19, 2025
Reference key: es13602
Permanent
Deadline date:

Job Description

  • Negotiable
  • Permanent
  • Galway

Senior Supplier Quality Engineer  – a global leader in medical device innovation in Galway, is looking for a Senior Supplier Quality Engineer I to spearhead supplier quality initiatives. This role involves managing supplier approvals, qualifications, and process validations, while ensuring compliance with ISO 13485, FDA QSR, and EU MDR regulations.

Responsibilities:

Supplier Management & Compliance

  • Lead supplier quality engineering activities, ensuring compliance with regulatory requirements.
  • Manage supplier approvals, audits, and process validations (IQ, OQ, PQ).
  • Build and maintain strong supplier relationships, ensuring collaboration, quality, and regulatory alignment.

Quality Leadership & Process Improvement

  • Provide leadership, training, and development within the Supplier Quality Team.
  • Implement continuous improvement strategies, using problem-solving and statistical techniques.
  • Oversee timely closure of Quality System documentation (Audit Actions, SCARs, SCNs, PANs).
  • Ensure adherence to GMP standards within projects and supplier interactions.

Project & Manufacturing Support

  • Support New Product Introductions (NPI), supplier transfers, and cost improvement projects.
  • Work with Manufacturing Quality to establish inspection plans and test methods.
  • Lead quality engineering efforts for design improvements and process optimizations.

What You’ll Need to Succeed:

Education & Experience

  • Bachelor’s Degree (BE/BS) in Engineering or a related field.
  • 6+ years of Quality Engineering experience in the medical device industry.
  • Postgraduate qualification in Quality Assurance (preferred but not required).
  • Strong knowledge of ISO 13485, FDA QSR standards and process validation methodologies.

Key Skills & Competencies

  • Proactive and self-motivated with strong leadership abilities.
  • Ability to identify and implement quality improvements.
  • Expertise in process validation (IQ, OQ, PQ) and supplier engagement.
  • Strong communication and organizational skills with keen attention to detail.
  • Ability to work collaboratively across departments and with suppliers.

Benefits:

Comprehensive Medical Coverage
Bonus & Pension Plan
Employee Engagement Programs
Commitment to Social Responsibility (1% Profits & Time to Charities)