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Job Description
Senior Quality Engineer role in Athlone, Ireland, with a hybrid work arrangement, requiring a third-level qualification in Engineering, Quality, Validation, or equivalent manufacturing experience.
Main Responsibilities
- Develop and implement solutions to sustain and improve the Quality Management System (QMS).
- Maintain and support compliance to required regulated systems standards.
- Interface with customers on new products, quality issues, and process qualifications.
- Develop and implement process control programs to ensure customer requirements are met.
- Carry out process validations and qualification on products.
- Provide manufacturing support and quality expertise in relation to manufacturing issues and product disposition.
- Perform quality engineering analysis to identify strategies to prevent quality nonconformances and minimize risk.
- Coordinate Non-Conformance Material Review (NCMR) and Corrective Action Preventive Action (CAPA) processes to ensure timely resolution and closure of issues.
- Lead training activities on Quality Procedures, such as Compliance, Good Manufacturing Practice (GMP), Audit Preparation, and Good Distribution Practice (GDP).
- Support and represent the site during external audits and carry out internal audits.
- Support Environmental, Health, and Safety requirements, training, and regulations.
Requirements
- Third-level qualification in Engineering, Quality, Validation, or equivalent manufacturing experience.
- Knowledge of CAPA's, NCMR's, Change Controls, and SCAR's from a Quality perspective.
- Experience in statistical analysis (Minitab) / Statistical Process Control (SPC) / validations.
- Excellent interpersonal, communication, influencing, and facilitation skills.
- A minimum of 3 years' experience as a Quality Assurance Engineer within medical device or pharmaceutical manufacturing environment.
About the Company
SL Controls is a leading expert in Equipment System Integration and System Support, specializing in assisting multinational companies in the medical device and pharmaceutical sectors achieve their Six Sigma and Overall Equipment Effectiveness (OEE) targets.