Senior Quality Engineer

SUMMARYThe primary role of the Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customers' quality requirements.The employee will be required to be at the office when Incoming Inspection/ field investigations are necessary.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.Develop project Quality Plans to enable new product implementation or changes to release product in an efficient way that satisfies regulatory requirementsActively identify process improvements and drive implementation of changes with stakeholdersConduct frequent and detailed quality checks to ensure processes are consistent with industry and legal requirementsReview Product Development deliverables to ensure they are completed accurately and efficientlySupport post market product monitoring, and generate metrics for the teamsWork with key stakeholders to develop and maintain QA procedures and formsDevelop and lead training for QA systems, create/ schedule/ conduct/ track yearly training and update the system. Maintain training records up to dateSupport the completion of risk assessment, as related to QA systemsPerform incoming inspection/ field investigationsManage or support the response to audit findings and CAPAsReview equipment qualifications (Installation, Operational, Performance)QUALIFICATIONSRequired5+ years of experience in engineering or science (Mechanical or Biomedical preferred)3+ years of experience with medical device quality compliance requirements including ISO13485, ISO14971 and FDA 21 CFR Part 820Knowledge of quality systems including Six Sigma, SPC, sampling plans, process mapping, inspection and testingExcellent communication skills to effectively provide written and verbal communication to supporting teamsAbility to effectively write reports, work instructions, and proceduresProven ability to interpret quality and regulatory requirements to "right-size" quality activities to meet compliance, business needs and riskAbility to exercise judgment in selecting innovative, practical methods to achieve problem resolutionLeadership and flexibility to work with the business to address quality risks and improvementsPreferredBachelor's degree in engineering or science (Mechanical or Biomedical Engineer preferred)3+ years of regulatory or clinical background experience is a plusExperience in bringing new product into productionInternal audit certificationCOMPUTER SKILLSProficiency with Microsoft Excel and PowerPointMINITAB is a plus