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Job Description
Seeking a Senior Quality Engineer to support Quality aspects impacting the successful functioning of a manufacturing facility, with a focus on developing and implementing solutions to sustain and improve the QMS.
**Job Description** Reporting to the Quality Manager, you will be responsible for supporting all Quality aspects impacting the successful functioning of the manufacturing facility. Key responsibilities include: * Developing and implementing solutions to sustain and improve the QMS * Maintaining and supporting compliance to required regulated systems standards * Interfacing with customers on new products, quality issues, and process qualifications * Developing and implementing process control programs to ensure customer requirements are met * Carrying out process validations and qualification on products * Providing manufacturing support and quality expertise in relation to manufacturing issues and product disposition * Performing quality engineering analysis to identify strategies to prevent quality nonconformances and minimize risk * Coordinating NCMR/CAPA Process to ensure timely resolution and closure of issues * Leading training activities on Quality Procedures, e.g., Compliance, GMP, Audit Prep, and GDP * Supporting and representing the site during external audits and carrying out Internal Audits * Supporting 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) / 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 customers in the medical device and pharmaceutical sectors achieve their Six Sigma and OEE targets. With a strong focus on employee development and wellness, we offer a competitive and rounded compensation package that rewards high performers.