Quality Engineer

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

Job summary

GxP Recruitment is seeking a Quality Engineer for a large medical device client in Galway. The role involves supporting line moves, equipment updates, CAPAs and ensuring product quality with independent authority to disposition non-conforming product.

You will participate in customer complaints investigations and drive continuous improvements to product and process quality, with strong knowledge of QSR and ISO/MDD standards and regulatory requirements.

Qualifications

• Degree in engineering or science discipline is required.
• 2–4 years’ engineering level experience, preferably in medical devices.

Responsibilities

• Work on projects related to line moves, equipment updates, CAPAs and related quality tasks.
• Have the responsibility and authority to disposition non-conforming product.
• Participate in customer complaints investigations for areas under your control.
• Drive continual improvements in product and process quality.
• Be familiar with QSR and ISO/MDD standards and promote best industry practices.
• Conduct validation activities and regulatory compliance analysis as needed.
• Analyze data to establish specifications and performance standards for new or modified products/processes.
• Possibly participate in new product/technology transfers ensuring regulatory compliance.
• Guide Associate Quality Engineer, Technician and Inspection staff as needed.
• Interact with suppliers and other engineering disciplines as required.
• Be familiar with internal auditing processes.

Skills

Six Sigma

Statistical Analysis

Lean principles

Quality awareness

Education

Bachelor's degree in Engineering or Science

Job description

We are working on an exciting Quality Engineer role for a large medical device client in Galway.

Note: no sponsorship is provided for this contract position, a valid working visa is required.

• Works on projects associated with line moves, equipment updates, CAPAs etc
• 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.
• 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.
• Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
• Is familiar with the internal auditing process.

Qualifications:

• A Level 8 Degree or equivalent in an Engineering or Science related discipline.
• A minimum of 2- 4 years’ experience working at Engineering level, ideally within the Medical Device industry.
• Previous Operations/Line Support within the medical device industry