Project Engineer

PE Global (UK); Dún Laoghaire; On-site; EUR 50,000 - 70,000; Full time

Job summary

An international manufacturing company is seeking a QA Validation Engineer for a permanent onsite role in Co. Westmeath. The successful candidate will ensure Quality Assurance in compliance with ISO standards, participate in internal audits, and assist with new product development. Candidates should have a Bachelor's degree in a related field and a minimum of 3 years experience at a quality engineer level in an ISO 13485 regulated environment.

Qualifications

• Minimum 3 years experience working at quality engineer level in an ISO 13485 regulated environment.
• Internal Auditor qualified to ISO 13485.
• Experience with equipment validation.

Responsibilities

• Implement and maintain quality system to international standard.
• Carry out internal audits to ISO 13485 standard.
• Support new product development, production trials, and sampling.

Skills

Quality Assurance

Internal Auditing

Problem Solving

Statistical Analysis

Attention to Detail

Education

Bachelor’s Degree in Science, Engineering or a related field

Job description

The role

PE Global is currently recruiting a QA Validation Engineer for a permanent role, with a leading international manufacturing client based in Co. Westmeath.

This is a full onsite role.

Description

Provide Quality Assurance support to ensure the Quality System is of the highest standard with particular focus on validations and non-conformances.

This position will report directly to the Quality Plant Manager.

Responsibilities

• Implement and maintain quality system to the international standard ISO 13485, ISO 9001 and all applicable regulations under the Medical Device regulation, including creation of new SOP’s and revision of existing documentation within the quality management system
• Carryout internal audits to the ISO 13485 standard.
• Partake as a key team member in customer and regulatory audits as required.
• Product Development: Participate in and support all aspects of new product development, production trials, sampling and production runs of new materials and finished products as needed.
• Monitor vendors and issue NCMR’s where necessary and ensure problem vendors are identified and controls implemented to prevent problem reaching product.
• Report on relevant quality performance data and drive continuous improvement processes within the organisation through change control activities.
• Manage investigation and closure of Validation Deviations, Non-conformances and CAPA’s, including support of the investigation processes when not the owner.
• Validation: Assist with the generation and execution, where required, of validation protocols and reports (IQ/OQ/PQ), including data analysis and test scripts as required.

Key Performance Indicators

• Quality Assurance Personnel: To learn from and to work as part of the Quality Team.
• Operations Lead / Production Manager: Liaise with production team on quality issues.

Decision making authority

• Decisions on product Quality flagged by Production, where problems arise these will be highlighted to the Quality Manager.

Education / Experience

• Bachelor’s Degree in Science, Engineering or a related field
• Minimum 3years experience working at quality engineer level in an ISO 13485 regulated environment.
• Internal Auditor qualified to ISO 13485
• Experience with equipment validation and statistical analysis is essential.
• Strong interpersonal, problem solving and attention to detail skills.
• The above is not exhaustive. Other duties and responsibilities may be added as the employee’s immediate supervisor deems appropriate.

Interested candidates should submit an updated CV

Please click the link below to apply, call Kellie on 086 0200448 or alternatively send an up to date CV to [e-mail].

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***