Senior Validation Specialist

2 weeks ago


Galway, Galway, Ireland beBeeExpert Full time €90,000 - €120,000
Quality Assurance Expert

We are seeking an experienced Quality Engineer who has a proven track record in quality and validation activities. The successful candidate will provide quality support for site operations, ensure compliance with industry standards, and collaborate with cross-functional teams.

The ideal candidate will have experience in quality assurance and excellent communication skills. You will be responsible for maintaining quality systems and driving continuous improvement initiatives.

Key Responsibilities:
  • Identify and resolve complex exceptions to work assignments.
  • Have the authority to make decisions related to product quality, including the disposition of non-conforming products.
  • Continually seek to drive improvements in product and process quality.
  • Knowledgeable on regulatory requirements, promoting awareness of best practices and making informed decisions daily.
  • Fully conversant with validation techniques and associated regulatory requirements.
  • Evaluate new equipment/processes/chemicals for environmental impact/effect.
  • Compile and analyze operational, test, and validation data to establish technical specifications and performance standards.
  • May participate directly in new product/technology transfer to ensure compliance with internal and regulatory requirements.
  • Apply knowledge of Six Sigma, Statistical Analysis, and Lean principles to investigate and solve problems.
  • Possess excellent collaboration skills.
  • Provide technical guidance to Quality Technicians.

Requirements:

  • A Level 8 Degree or equivalent in an Engineering or Science-related discipline.
  • A minimum of 2 years' experience working at Engineering level, ideally within the Medical Device industry or similar highly-regulated sectors.
  • Experience with internal and external audit processes.
  • A team player, demonstrating best practices in line with departmental objectives and fully motivated to achieve.

Benefits:

  • Competitive employee compensation package.
  • Pension contributions.
  • Health insurance.
  • Paid public holidays.

Location: Galway, Ireland | onsite.



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