Senior Quality Engineer - Medical Devices & Compliance

GxP Recruitment; Connacht; On-site; EUR 52,000 - 75,000; Full time

Job summary

GxP Recruitment is seeking a Quality Engineer to uphold the site Quality Policy, ensuring patient safety and product quality within a regulated medical device environment in Ireland. You will apply sound quality practices and maintain the quality system daily.

Responsibilities include internal audits, disposition of non-conforming product, investigations of customer complaints, and driving continuous improvements using Six Sigma, statistical analysis and Lean methods in line with BSEN 14971 risk

Qualifications

• A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.
• 3–5 years’ experience at Engineering level, ideally in Medical Device or other highly regulated environment.
• Familiar with Internal Audit Processes.
• Team player with motivation to achieve site objectives.

Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions from test results or process findings.
• Disposition of non-conforming product with independent authority.
• Participates in Customer Complaints investigations for areas under their control.
• Drives improvements in product and process quality.
• Promotes awareness of best industry practices and regulatory requirements.
• Evaluates environmental impact of new equipment/processes for safety and sustainability.
• Accounts for risk management per BSEN 14971 requirements.
• Supports validation techniques and regulatory requirements analysis.

Skills

Quality engineering

Six Sigma

Statistical analysis

Lean principles

Regulatory compliance

Audit processes

Problem solving

Education

Bachelor's degree in Engineering or Science

Job description

GxP Recruitment is seeking a Quality Engineer to uphold the site Quality Policy, ensuring patient safety and product quality within a regulated medical device environment in Ireland. You will apply sound quality practices and maintain the quality system daily.

Responsibilities include internal audits, disposition of non-conforming product, investigations of customer complaints, and driving continuous improvements using Six Sigma, statistical analysis and Lean methods in line with BSEN 14971 risk