Design Quality Engineer Clinton, PA at Haemonetics

We 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 DetailsJob Summary:Support the quality system by ensuring compliance to and enforcing regulations standards policies standard operating procedures and instructions related to design control of Haemonetics products. Effective member of assigned cross-functional design teams supporting new product development and sustaining engineering change management.Essential Functions:SUPPORT NEW PRODUCT DEVELOPMENT & PRODUCT CHANGE MANAGEMENT PROJECTS BY:Represent Quality department as cross-functional team member for product portfolios new product development projects and product change projectsSupport detail tracking through project deliverables such as project quality plans and safety assessments and perform updates and release to documents within the electronic systemParticipate in:Translation of Voice-of-Customer into development RequirementsDevelopment update and release of various risk management documentationSupport development team in the creation review and approval of:Engineering Requirements & SpecificationsEngineering test protocols and reports required for design verification design validationDefine statistical sampling and testing methods required for verification and validation testing and provide measurement analysis support as requiredEnsure accuracy and completeness of the Design History File and the Device Master RecordAbility to support multiple Product Line PortfoliosProvide quality engineering support for process development implementation improvement and validation efforts as assignedProvide Post Market Surveillance complaint investigation technical supportSUPPORT QUALITY SYSTEM BY:Leading or participating in continuous improvement projects as well as improvements to policies procedures instructions and trainingEnsuring the ongoing readiness of the Quality Management System for external and internal audits and participating in audits and inspections as requiredEnsuring compliance to and enforcement of applicable regulations standards Haemonetics policies / proceduresQualifications:Minimum of 3 years medical device or IVD product development and design quality engineering experienceB.S. in Biomedical Mechanical Electrical or other appropriate Engineering degree.Good working knowledge of medical device design control process including risk management and design transferStrong team collaboration with ability to handle multiple tasks in a fast pace new product introduction environment.Manufacturing process validation knowledge and experienceFamiliar with medical device Quality Management SystemsEEO Policy Statement Key Skills Business,Baan,Communication,Corporate Advisory,HSSE Employment Type : Full-Time Experience: years Vacancy: 1