Quality Engineer

HERO Recruitment; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

HERO Recruitment is seeking an experienced Quality Engineer in Galway for a 6 month contract with potential for extension or permanency. You will uphold the Quality Policy, ensure patient safety and product quality, and drive continuous improvement within a regulated quality system.

The role requires 3+ years in a medical device or highly regulated environment, with strong analytical and problem-solving skills and experience with audits, CAPAs, and risk management.

Qualifications

• Bachelor's level degree in a STEM field.
• 3+ years of relevant experience in medical device or highly regulated environment.
• Experience applying risk management and design controls.
• Familiarity with ISO/MDD/MDR quality systems and audits.

Responsibilities

• Proactively identify quality issues and prevent non-conformances.
• Maintain and improve the quality system to ensure patient safety.
• Plan and execute daily tasks and long-term quality projects.
• Lead investigations, containment, disposition, and CAPAs.
• Communicate complex technical topics clearly to stakeholders.
• Support internal and external audits and provide SME input.

Education

A Level 8 Degree or equivalent in a STEM discipline

Tools

Six Sigma

Lean Principles

Statistical Analysis

Job description

6 Month Contract with potential to be extended or be made permanent

Galway

Job Purpose:

As an experienced Quality Engineer, you will demonstrate commitment to the Quality Policy (patient safety and product quality) through daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Committed to patient safety and product quality.

Key Responsibilities:

• Takes a preventive approach to Quality Assurance, proactively identifying potential issues.
• Uses strong organisational skills and effective time management to ensure work is completed in a timely manner.
• Effectively prioritises a diverse workload to ensure timely completion of critical tasks.
• Plans and executes both daily tasks and long-term projects to ensure timelines are met.
• Takes a pragmatic and logical approach to challenges faced.
• Explains technical topics clearly to diverse stakeholders through effective communication.
• Promotes a culture of continuous improvement through reflection and factoring in previous learnings.
• Makes informed decisions related to product quality, including dispositioning non-conforming product.
• Evaluates complex quality issues and selects the most appropriate problem-solving tools/ techniques.
• Completes timely scoping and containment of product-related issues when required.
• Documents non-conformances using a high standard of technical writing and detailed understanding of Containment, Disposition, Risk Assessment and Investigation.
• Identifies and drives Corrective Actions when required, to prevent/ eliminate/ facilitate/ mitigate the re-occurrence of non-conformances.
• Reviews Complaints’ signals and completes investigations for individual events/ unfavourable trends.
• Familiar with BSC Quality Systems and ISO/MDD/MDR standards.
• Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert.
• Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation.
• Uses appropriate statistical tools for sampling, capability, trend analysis, and control charts. Effectively interprets and presents conclusions drawn.
• Participates directly in a new product/technology transfer, ensuring compliance to all internal and regulatory requirements.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean Principles to solve problems effectively.
• Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver.
• Evaluates new equipment/processes/chemicals for safety and environmental impact/effect, in conjunction with EH&S.
• Completes validations for processes/ test methods in line with requirements and best practices.
• Maintains relationships and gives technical guidance to Quality Technicians.
• Deals with suppliers, other engineering disciplines within and outside of the site as required.

Education & Experience:

• A Level 8 Degree or equivalent in a STEM discipline.
• A minimum of 3+ years relevant experience, ideally within the Medical Device industry or another highly regulated environment.