Quality Engineer

Dillon Engineering Services; Sligo; On-site; EUR 52,000 - 65,000; Full time

Job summary

Dillon Engineering Services in Sligo is seeking an experienced Quality Engineer for a 12-month contract to support QA, product compliance and continuous improvement across manufacturing operations.

The role focuses on maintaining the QMS, ensuring products meet specs and compliance with cGMP, ISO 13485, ISO 9000 and FDA 21 CFR Part 820.

You will lead CAPA, audits, batch review, supplier quality and risk management while collaborating with cross-functional teams.

Qualifications

• Degree in Engineering, Science, Quality or related discipline.
• >2 years' experience with a Quality Management System in a regulated manufacturing environment (medical devices preferred).
• Knowledge of ISO 13485, ISO 9000 and FDA 21 CFR Part 820.
• Experience with quality investigations, non-conformances and controlled documentation.
• Strong attention to detail and compliance.
• Ability to work independently with cross-functional teams.
• Experience in injection moulding/plastics manufacturing.
• Lean Six Sigma Green Belt or statistical methods knowledge.
• Experience with batch record review and product release.

Responsibilities

• Coordinate and maintain the QMS elements for regulatory compliance.
• Manage CAPA investigations, root cause and effectiveness.
• Support internal quality audits and address findings.
• Assist with customer complaint investigations and follow-up.
• Review batch and lot records for compliance and release.
• Support incoming materials inspection and final release testing.
• Work with suppliers to address quality issues.
• Participate in process and product validation.
• Support regulatory compliance with ISO 13485, ISO 9000, FDA 21 CFR Part 820.
• Monitor quality metrics and support management reviews.
• Assist training and ensure training compliance.
• Participate in risk assessments and continuous improvement.
• Follow environmental, health and safety procedures.

Skills

Quality management

CAPA investigations

Documentation control

Problem solving

Cross-functional collaboration

Regulatory compliance

ISO 13485

FDA 21 CFR Part 820

Injection moulding/plastics

Lean Six Sigma Green Belt

Education

Engineering/Science degree

Tools

QMS systems

Job description

We are seeking an experienced Quality Engineer to join a quality team within a highly regulated manufacturing environment in Sligo. This 12-month contract offers an opportunity to support quality assurance, product compliance and continuous improvement activities across manufacturing operations.

The successful candidate will help maintain and improve the site's Quality Management System (QMS), ensuring products meet approved specifications and that manufacturing activities comply with current Good Manufacturing Practice (cGMP) and applicable regulatory requirements.

Key Responsibilities

• Quality Management System: Coordinate and maintain assigned elements of the QMS, ensuring compliance with internal procedures and regulatory requirements.
• CAPA and Investigations: Manage day-to-day Corrective and Preventive Actions (CAPA), including investigations, root cause analysis, corrective actions and effectiveness checks.
• Quality Audits: Support internal quality audits and ensure findings are appropriately addressed.
• Customer Complaints: Assist with complaint investigations, identify potential quality risks and coordinate appropriate follow-up actions.
• Documentation and Batch Review: Review batch and lot records, verify documentation compliance and support batch disposition and product release activities.
• Product Quality and Testing: Support incoming material inspections, in-process checks and final product release testing against approved specifications.
• Supplier Quality: Work with suppliers to address quality issues and maintain appropriate quality standards.
• Validation: Participate in process and product validation activities as required.
• Regulatory Compliance: Support compliance with applicable quality standards, including ISO 13485, ISO 9000 and relevant FDA regulations.
• Quality Metrics and Reporting: Monitor QMS performance, prepare quality metrics and contribute to management reviews and reporting.
• Training and Compliance: Support employee training on quality procedures and maintain compliance with training requirements.
• Risk Management and Improvement: Participate in risk assessments, continuous improvement initiatives and activities aimed at improving product quality, safety and manufacturing performance.
• EHS Compliance: Follow environmental, health and safety procedures and actively contribute to a safe working environment.

Requirements

• A degree in Engineering, Science, Quality or a related discipline, or equivalent relevant experience.
• More than two years' experience working with a Quality Management System in a highly regulated manufacturing environment, ideally involving medical devices or combination products.
• Practical knowledge of quality system requirements, including ISO 13485, ISO 9000 and FDA 21 CFR Part 820, or relevant elements such as CAPA, auditing, process validation and design controls.
• Experience with quality investigations, non-conformances, corrective actions and controlled documentation.
• Strong attention to detail and a commitment to maintaining high quality and compliance standards.
• Proven problem-solving skills and the ability to work independently while collaborating with cross-functional teams.
• A proactive approach to identifying quality issues, implementing improvements and driving actions through to completion.
• Experience in injection moulding, tooling or plastics manufacturing.
• A Lean Six Sigma Green Belt qualification or demonstrated knowledge of statistical methods in an industrial environment.
• Experience with batch record review, product release and supplier quality management.

What We're Looking For

We are looking for a Quality Engineer who takes ownership of their work, applies a Right First Time approach and is confident managing quality issues through to resolution. You will bring a strong understanding of regulated manufacturing requirements, sound technical judgement and a continuous improvement mindset.

Work Authorisation: Only candidates who are legally authorised to work in Ireland will be considered for this role