Senior Quality Engineer

Description

Summary: Novem Medical is seeking a Senior Quality Engineer responsible for ensuring product compliance, regulatory adherence, and continuous improvement of the Quality Management System. Highlights: 1. Ensure products meet predetermined requirements and regulatory compliance 2. Lead product recall activities and investigate customer complaints 3. Develop and maintain quality system documentation **Novem Medical is seeking a Senior Quality Engineer** Responsible to ensure that products released at the different production stages meet all predetermined requirements, and production activities are performed in regulatory compliance per FDA 21 CFR part 820 and ISO 13485:2016\. Coordinates and executes activities required to achieve the quality performance metrics and guarantee the continuous effectiveness of the QMS. Main functions and responsibilities * Coordinates and executes activities to achieve the targets for the quality performance metrics. * Leader of product recall activities. * Follow up with owners of CAPAs, NMRs, Customer Complaints to ensure these are addressed on a timely manner. * Ensure Regulatory Compliance with FDA 21 CFR part 820, ISO\-13485:2016\. * Provide support to other departments for cost saving projects and scrap reduction projects. and quality improvement projects. * Leads and develops quality improvement projects to reduce nonconformances reported in NCMR and customer complaints. * Execute Internal Audits and provide support on external audits. * Develops, modifies and maintains updated the quality system documentation. * Reviews the performance of subordinates and recommends the training plans. * or processes validation. * Collects, analyzes and present quality performance metrics for daily meetings and management review meetings. * Leader of investigation of customer complaints and coordinates with other departments the implementation of corrective actions. * · Escalate nonconformances related to raw materials, follow up with suppliers to resolve the quality issues. * Ensure the proper implementation of the calibration system. * And maintaining the integrity of Controlled Environment Roomç * *Additionally, the employee may participate in other work activities in support of the various strategic objectives of the Company.* Immediate availability Excellent command of English Statistical skills Proficiency in ISO 13485 Sueldo: A partir de $1\.00 al mes Lugar de trabajo: Empleo presencial