Quality Sr Engineer
hace 2 semanas
Quality Sr Engineer**Job Number**:QUA0101IB )**Primary Location **: Mexico-Baja California Norte-Mexicali**Description**:The Senior Quality Engineer executes and coordinates Quality Engineering functions with a focus on continuous improvement of sterile and non sterile products and processes for MXC site. Leads the execution of initiatives and projects to enhance quality performance. Assures compliance to all applicable regulatory requirements and standards (ISO13485, MDSAP, 21CFR Part 820 FDA ). Partnering with QC and Manufacturing Engineering to manage continuous process/quality improvement programs, corrective and preventive (CAPA) activities in process as well as customer requirements. Participate in the internal audit program as Internal Auditor, support external audits (customer and third parties) as required.Support Production Operation by Identifying in-process opportunities and implement solutions to drive continuous improvement through CAPA systemInvestigate product quality problems and customer complaints to determine root cause to reduce or eliminate causes.Communicate product quality issues and trending information for Management as applicable.Define, and lead continuous improvement projects focused on quality improvement, and cost reductions.Support the implementation and improvements for Good Manufacturing Practices (GMPs).Support on process validation per FDA requirements.Update documentation (procedures, form etc) as needed to reflect current or improved practices.Participate on the QMS internal audit program as internal auditor and support on external and third party audits as required.Ownership for Quality Projects within the department.Provide Quality Engineering support to Production, QC and Engineering.Collaborate with Engineering department on projects and implementations.Maintain effective communication with Corporate counterparts.Participate in FMEA activities as the quality representative.Support in the planning and execution of the Quality Week activities.Participate in the different programs and iniciatives of the organization as required.**Qualifications**:**Education**:Industrial, Electrical, etc3-5 years of Quality Control/Engineering experienceMedical Devices ExperienceInternal / Lead Auditor ISO 13485:2016MDSAP knowledge / experienceOffice Windows: Word, Excel, Power Point, etc.Strong leadershipeffective communicationManagement skills / Decision MakingSix Sigma (BB/GB)Lean Manufacturing Experience
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