Talent.com
This job offer is not available in your country.
Senior Quality Engineer

Senior Quality Engineer

CplGalway
30+ days ago
Job description

Now Hiring : Senior Quality Engineer

Location : Galway (Ballybrit Business Park)

Type : Full-Time | Permanent

About the Company :

Our client, is a young, fast-growing med tech company working on a new and less invasive way to treat Benign Prostatic Hyperplasia (BPH), a condition affecting over 50% of men over 50. As the company grows, they’re looking for a Senior Quality Engineer to support development and manufacturing efforts.

Role Overview :

As a Senior Quality Engineer, you will play a critical role in driving quality assurance activities that support product development, manufacturing, and regulatory compliance. You will work closely with cross-functional teams including R&D, operations, and suppliers to maintain and improve quality systems and processes in line with ISO and FDA regulations.

Key Responsibilities :

  • Support and maintain the Quality Management System (QMS), ensuring compliance with ISO , 21 CFR , and applicable regulatory standards.
  • Assist in the execution and coordination of internal and supplier audits, including supplier performance monitoring and quality agreements.
  • Lead investigations and root cause analyses for nonconformances (NCRs), customer complaints, and CAPAs, ensuring timely resolution and documentation.
  • Develop, review, and approve quality documentation including validation protocols, reports, and manufacturing process controls such as PFMEAs.
  • Collaborate with manufacturing and operations teams to support lot release activities, including sterilization validation and routine quality checks.
  • Participate in management reviews, quality review meetings, and data analysis to provide actionable insights for continuous improvement.
  • Provide quality input and support to internal projects and product lifecycle activities.
  • Liaise with external auditors and regulatory bodies during inspections and audits.
  • Facilitate communication of quality requirements across functional teams to ensure awareness and compliance.
  • Support updates to the QMS in response to evolving regulatory or business needs.

Qualifications & Experience :

  • Bachelor’s degree in a scientific or engineering discipline.
  • 5+ years of quality engineering experience in the medical device or pharmaceutical industry.
  • Solid understanding of ISO , FDA QSR (21 CFR ), and regulatory requirements for medical devices.
  • Strong problem-solving skills with experience in CAPA, NCR, risk management, and root cause analysis.
  • Experience working with suppliers and subcontractors on quality oversight activities.
  • Excellent written and verbal communication skills, able to collaborate effectively with cross-functional teams.
  • Demonstrated ability to work independently in a fast-paced, evolving startup environment.

    • Apply today or reach out to to learn more.

    LI-EB6

    Create a job alert for this search

    Quality Engineer • Galway