In the role of Senior Quality Engineer at our Danvers, MA production site, you hold a pivotal position in the success of the Quality and Manufacturing organizations.
Your main responsibilities include : Acting as a steward for product and process quality, offering expertise in the evaluation of change control for Mobius products at Danvers and across various sitesLeading and overseeing product quality investigations in collaboration with R&D, Manufacturing, Validation, and plant engineering, guaranteeing thorough root cause analysis, impact and risk assessment, and the implementation of corrective actionsSupporting process improvement activities with specific focus on right first-time quality metrics, including reduction in non-conformances, reworks, and customer complaintsLeading the execution of Organization Level Agreements, including quality commitments and quality improvement projects, and collaborating with stakeholders and project teams to ensure successful implementationOffering guidance, support, and technical expertise to assist other team members in achieving success Weekday Shift : Monday-Friday Who You Are : Minimum qualificationsAssociate’s degree in engineering, applied engineering, sciences or related fieldMinimum of 3 years of relevant and progressive work experience Preferred QualificationsBachelor’s degree in engineering, applied engineering, sciences, or related fieldStrong people leadership, project management, and problem-solving skills with a proven track record of prioritization and change managementBasic understanding of material analysis tools and techniques i.
e., FTIR, DSC Calorimetry, microscopy, particle counters, and integrity testing by pressure decayDetailed understanding of equipment and process validation and qualification in a regulated industry including associated toolkits i.
e., p / dFMEA, statistical process control, sampling plansUnderstanding of investigations, impact assessment workflow in a regulated environment subject to time constraints.
An understanding of change control process in a regulated industryLean Six Sigma and / or root cause analysis trainingExperience with Quality Systems (e.
g., Deviation, CAPA, Change Control, Documentation Management)Proven track record of working collaboratively and communicating successfully in a cross-functional and multi-cultural environmentDemonstrate strong quality knowledge : GMP / GDP, ISO standardsAbility to adapt and thrive in a constantly changing business environmentProficient in computer skills pertaining to MS Word, MS Excel, MS PowerPoint, MS Teams, MS SharePoint to support data review, analysis and sharing
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