Quality Engineer

Job DescriptionProvide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.Lead Investigation into quality related events.Manage quality systems elements, including the non-conformance, CAPA, risk management, internal audits and document controlSupervise Quality TechniciansEnsure all process variables and their interactions are adequately defined.Ensure all failure modes in process have been identified and addressed. ( Use of DOE studies, FMEA’s/ PCAs).Drive and implement plant wide quality system improvements.Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies ( FDA and TUV).Assist in the implementation of EUMDR requirements.Provide expertise to various functions on quality related issuesIdentify and implement appropriate statistical techniques to monitor process performance ( SPC, CpK analysis, sampling techniques).Approve change requests for product, process and quality system changes.Define process, product and test method validation requirements, prepare and approve Master Validation Plans, protocols and reports approval.Compilation of required Regulatory documentation ( files, Design Dossiers, Product transfer files, Essential requirements).Review of MRB trends and identification of appropriate corrective actions when required.Develop, monitor, and report on trending metrics associated with the quality system.Support the implementation of Lean Manufacturing across the site.Transfer and implement product and processes from development or from another manufacturing facility.Drive and implement process improvements to ensure predictable processes across all product lines ( Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).At all times, adopt a safe behavior by exercising due regard for the health and safety of yourself, colleagues, and clients, in line with the Company’s policies and procedures.Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and always adopt behavior in accordance with SGS Equality & Diversity policy.QualificationsMinimum of Bachelor of Science Degree in Engineering/Technology.A minimum of 3 years’ experience in a manufacturing environmentExperience in a QA environment (GMP is preferred).Experience in the med device industry is desriable