Quality Engineer

Establish and maintain sound relationships with QM, quality teams and cross functional personnelEngage with CAM (Customer Service), operations, IT and engineering personnel to identify system and compliance gaps with proposed resolutionsWork with operations and other teams to investigate and determine corrective actions related to customer complaintsWorks very closely with commercial teams and Account Managers on customer related issuesEnsure that quality systems satisfy and meet at all times all customer specifications, internal and regulatory requirements (ISO, GMP, FDA)Participate in internal and customer related quality activitiesEngage in customer and third party visits and auditsResponsible for investigating and implementing corrective actions related to customer audit findingsReview customer specifications and sign offDevelop quality control plan for products as requiredDemonstrate quality performance by trending and trackingAnalyze data and present to the site management teams to identify quality improvement projects and focus areas Reduce internal quality issues to meet and exceed set targetsEngage in risk assessment process; identification, control and management utilizing risk assessment tools such as FMEASupport new product and line launches by working with Sales and Marketing, Engineering and Product DevelopmentEstablish a comprehensive service model for customer complaint resolutionParticipate in CAPA steering committee and lead assigned CAPA and continuous improvement activities.Utilize Six Sigma tools and participate in Kaizen events to create improvement and permanent positive change. Engage personnel in problem solving and risk assessmentsChampion, facilitate, participate in projects as assignedFollow company policies and procedures at all times with ethical behaviour that delights co-workers, suppliers and other interacted partiesWork safe and encourage all employees to work safe as wellCommunicate immediately quality issues that bear high risk to the business and customerTreat all co-workers with respect and integrity, valuing inputs and feedbacksEnsure best practices are identified and shared among company sitesIdentify and communicate effective and efficient risk eliminationmitigation models practiced at company sitesMeet and exceed target of customer credit dollarsMeet Customer Complaint closure rate of 95% within 30 calendar daysDecrease number of customer complaints to meet and exceed current target100% safety record Knowledge and Experience3+ years relevant working experience in QualityPrevious experience in operations, process engineering andor process control preferredKnowledge and hands on experience in implementing and maintaining quality system standards (ISO 13485 and ISO 9001)Knowledge of the packing industry is preferredKnowledge of Medical Device and Pharmaceutical packaging is preferredKnowledge of Quality System Software and Quality Engineering toolsExperience with Lean Manufacturing, Six Sigma processes and tools is preferred Education and CertificationsUniversity degree in Engineering; Industrial or Packaging Engineering degreeSix Sigma Green Belt; Certified Quality Engineer through ASQ preferredStrong computer skills in Excel, Word, PowerPoint, Minitab & Lotus Notes

Created: 2025-02-21