
Senior Validation Specialist
2 weeks ago
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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