Senior Quality Assurance Specialist

7 days ago

Sligo, Sligo, Ireland beBeeValidation Full time €55,000 - €85,000
Job Title: QA Validation Engineer

We are seeking a highly skilled professional to coordinate the development and maintenance of our site validation program. As a key member of our team, you will be responsible for ensuring that our processes and systems meet the highest standards of quality and regulatory compliance.

Main Responsibilities:
  • Coordinate and participate in the validation and quality assurance of site equipment, utilities, processes, and software.
  • Develop and implement Site Validation Master Plans and Project Validation Plans, ensuring alignment with industry regulations and company standards.
  • Generate validation protocols, final reports, investigations, and corrective actions, highlighting key findings and recommendations.
  • Create, review, and approve quality documents and test data, guaranteeing accuracy and integrity.
  • Manage validation, exception event, and change control processes, promoting a culture of continuous improvement.
Requirements:
  • Degree in engineering or a scientific discipline, preferably related to the medical device industry.
  • Minimum 3 years of experience in validation/Quality in medical device plastics processing, moulding, or assembly operations, with a strong track record of delivering high-quality results.
  • In-depth knowledge of cGMP and regulatory requirements relating to the medical device industry, including FDA guidelines and ISO standards.
  • Strong communication, presentation, and troubleshooting skills, with the ability to work effectively with cross-functional teams and stakeholders.
About Us:

We are committed to providing a dynamic and supportive work environment that fosters innovation, collaboration, and growth. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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