Project Quality Engineer

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

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their 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.

Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Participates in Customer Complaints investigation for areas under their control.
• Continually seeks to drive improvements in product and process quality.
• Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis 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.
• Knowledgeable on Risk Management , BSEN 14971 requirements.
• 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.
• Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
• Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
• Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.

What we need from you:

• A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.
• A minimum of 3- 5 years’ experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
• Familiar with Internal Audit Processes.
• We would like you to be a team player and someone who is fully motivated to achieve and demonstrate best practices in line with the department and site objectives.