Quality Engineer

GxP Recruitment; Clonmel; On-site; EUR 45,000 - 65,000; Full time

Job summary

A growing medical device client in Clonmel is seeking a Quality Engineer to oversee product quality and drive process improvements. The role requires a Level 8 Degree in Engineering or Science, with 2-3 years of relevant experience in the medical device industry. Applicants must have strong knowledge of quality standards, validation techniques, and be able to work independently on quality-related decisions. This position does not provide sponsorship and requires a valid working visa.

Qualifications

• Minimum 2-3 years’ experience working at Engineering level, ideally within the Medical Device industry.
• Familiar with the internal auditing process.
• Experience in Operations/Line Support within the medical device industry is a huge advantage.

Responsibilities

• Works on projects associated with line moves, equipment updates, CAPAs.
• Has the independent authority to make decisions related to product quality.
• Participates in Customer Complaints investigation.
• Seeks to drive improvements in product and process quality.
• Knowledgeable on QSR and ISO/MDD standards.
• Compiles and analyses operational, test and validation data.

Skills

Six Sigma

Statistical Analysis

Lean principles

Education

A Level 8 Degree or equivalent in an Engineering or Science related discipline

Job description

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

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- 3 years’ experience working at Engineering level, ideally within the Medical Device industry.

• Previous Operations/Line Support within the medical device industry is a huge advantage.