Senior Quality Systems Specialist

4 days ago

Galway, Galway, Ireland beBeeQuality Full time €98,000 - €118,000
Quality Engineering Specialist

We are seeking a Quality Engineering Specialist to support our organisation in developing and maintaining quality systems. The ideal candidate will have a strong background in quality engineering, with experience in implementing ISO 13485:2016 and 21CFR Part820 compliant quality systems.

The successful candidate will manage document control functions, ensuring consistent and compliant processing of documents. They will also represent the quality function at functional team meetings, providing advice and completing documentation reviews.

In addition, they will participate in risk management, ensuring all risks are captured and mitigated according to ISO 14971:2019 requirements. They will liaise with technical operations to ensure high-quality product delivery in compliance with procedures and regulations.

The Quality Engineering Specialist will prepare quality system metrics for management meetings and reviews. They will address customer complaints in compliance with regulations and adhere to vigilance and reporting requirements.

Key Responsibilities:

  • Implement and manage quality systems in compliance with ISO 13485:2016 and 21CFR Part820.
  • Manage document control functions to ensure consistent and compliant processing of documents.
  • Represent the quality function at functional team meetings and provide advice and complete documentation reviews.
  • Participate in risk management to ensure all risks are captured and mitigated according to ISO 14971:2019 requirements.
  • Liaise with technical operations to ensure high-quality product delivery in compliance with procedures and regulations.

Requirements:

  • Bachelor's degree in Science or Engineering.
  • A minimum of eight years' experience in a quality engineering or regulatory role.
  • Excellent written, interpersonal communication, and presentation skills.
Benefits

This is an excellent opportunity for a motivated individual to advance their career in quality engineering. If you are looking for a challenging role that requires strong analytical and problem-solving skills, this could be the perfect fit for you.

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