Quality Systems Engineer Ii

OverviewWe are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.Job DetailsEnsures that processes needed for the quality management system of Haemonetics are established, implemented and maintained. Responsible to ensure the completeness of documentation package submitted to Agile Product Lifecycle Management and maintain the integrity of the HaemoLearn learning system data.Essential DutiesConducts internal or external audits as assigned to ensure compliance to company quality system requirements.Generates daily, weekly, or monthly trending reports; seeks to improve reporting processes to ensure unified approach and procedures.Presents reports and materials at business unit meetings and updates reports as appropriate with any key issues or customer concernsManages the process to gather and communicate quality systems Key Performance Indicators across the organizationDevelops, reviews and challenges existing quality driven test systems and procedures to assure products meet intended useResponsible in release of product to / from sterilization and to make disposition of the inspected component and product.Insures that full range of six sigma tools are used when appropriate for product and process changes in Braintree plan, particularly new products.Key contributor in the design review of new or modified products.Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards.Leads product improvement projects and consults on supplier changes to ensure qualifications are met.Leads teams / projects related to Complaint investigation, NCE, cost reduction, and quality system excellence.Use of TQM tools including six sigma is requiredReview and approve test report, calibration logs, and any other documentations.Establish, maintain, review and approve documents / records to ensure compliance to GMP / ISO requirementsMay lead design review of new platforms and assures that appropriate tests are performed to achieve sigma level expectations for qualityMay maintain an active role in supplier and new business assessment and development.May manage and lead NCE / CAPA program, implementing global NCE / CAPA policiesRequired to have specific product or process expertise to fit business needsComply with the ISO Environmental Management System policy, SOP and requirementsContinuous support to the development and implementation of program to achieve and maintain the ISO environmental management system.Perform other tasks as required.Supervisory Responsibilities : NoneQualificationsEducationBachelor's Degree : In Engineering / science or equivalent - RequiredExperience1 to 3 years or Fresh Graduate : In manufacturing environment or fresh graduate (as training will be provided) - PreferredSkillsStrong interpersonal skills required for interacting with external agencies and regulatory agencies to explain company policies, procedures and processes, with respect to their facility / product family is requiredAbility to communicate status performance of QMS to top management and to communicate regulatory and statutory requirements to all levelsDemonstrate knowledge of problem solving techniques and statistics (e.g. six sigma methodology)Able to be depended and extremely attentive to accuracy and detail at workProficiency with practical knowledge in ISO , ISO Environmental Management System, FDA 21 CFR Part 820, EU Medical Device Directive requirements, Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (EU MDR ), Good Distribution Practice for Medical Devices (GDPMD).Training / CertificationsISO , 21 CFR 820, 21 CFR 11 and GDPMD requirementsComputer proficiency using Microsoft Work, Excel, or similar programsSystem / Tool AccessComponent Engineer; Creator can read and discover object he or she created; Haemo Auditee; Haemo NCE Owner; Item Content Manager; Quality Administrator; Quality AnalystAuditingPhysical DemandsSit; use hands to finger, handle, or feel objects, tools, or controls.Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.Lifting / moving up to 10 pounds.Travel ExpectationsOccasional %EEO Policy Statement #J-18808-Ljbffr