QA Validation Engineer

Oxford Global Resources; Galway; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading recruitment agency is seeking an experienced Quality Engineer in Galway, Ireland. The ideal candidate will have a strong background in quality assurance, with experience in the Medical Device industry and a Level 8 degree. You will be responsible for ensuring compliance with quality standards, driving continuous improvement initiatives, and collaborating with cross-functional teams. Competitive compensation package with benefits offered.

Benefits

Competitive compensation package

Pension contributions

Health insurance

Paid public holidays

Qualifications

• 2+ years of experience at Engineering level, ideally in Medical Device industry.
• Experience with internal and external audit processes.
• Ability to promote best practices and achieve department objectives.

Responsibilities

• Identify and resolve complex work assignment exceptions.
• Make decisions related to product quality.
• Drive improvements in product and process quality.
• Ensure compliance with MDR and QSR standards.
• Evaluate new equipment for environmental impact.
• Analyze operational, test and validation data.
• Participate in product/technology transfers.
• Use Lean principles to improve quality.
• Provide technical guidance to Quality Technicians.

Skills

Quality assurance

Effective communication

Problem solving

Six Sigma

Collaboration

Education

A Level 8 Degree in Engineering or Science-related discipline

Job description

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Job Description

Our client is seeking an experienced Quality Engineer who has proven success in quality and validation activities. You will provide quality support for site activities, ensure compliance with standards and collaborate with cross-functional teams. The ideal candidate will have experience in quality assurance and will have the ability to communicate effectively. You will be responsible for maintaining quality systems and continuous improvement initiatives.

Key Responsibilities:

• Identifies and resolves complex exceptions to work assignments
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product
• Continually seeks to drive improvements in product and process quality
• Knowledgeable on MDR and QSR standards, constantly promoting awareness of best industry practices, making appropriate decisions daily utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
• Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes
• May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements
• Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality
• Possesses excellent collaboration skills
• Gives 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
• Experience with internal and external audit processes
• A team player, who can demonstrate best practices in line with the department and site objectives and someone who is fully motivated to achieve.

Benefits

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

Location: Galway, Ireland | onsite