Apply Sustaining Design Quality Engineer Job Post Index 21E776-Sy## Location Westford, MA Description: Job DescriptionAssures new or modified products conform to quality standards and establishes compliance with the quality system. Build hardware and software Lead the view in design and help with fixing the process.Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.Execute and support on-time completion of Design Control DeliverablesSupport on-time execution of Quality Plans for internal development, OEM-based and design change projectsAccountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activitiesLead or support Risk Management activities from product Concept through CommercializationSupport design test and inspection method development, and lead method validation activitiesEnsure DHF content completion, integrity, and regulatory and standards complianceCollaboratively communicating and resolving gapsSupport manufacturing process development and qualification for new product commercialization and product changesSupport internal and external audit responsesSupport product re-certificationsSupport the establishment of objective, measurable, discrete, and verifiable customer and product requirementsLeads CAPA for design issues coming from manufacturing, complaints and improves design.Support objective component specification definitions, supplied component sampling plan development, and vendor qualificationsSupport execution of biocompatibility and sterilization qualificationsComplete Document Change Request Reviews in a timely and objective mannerSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Skills: QualificationsMinimum Bachelors degree in Engineering 5 years experience in medical device industry with products meeting quality system requirement of ISO13485 and 21CFRPart 820 FDA as a Supplier Quality Engineer.5 years experience in material qualification, material specification development and supplier process validation 5 years experience in finished good process validation, developing inspection test methods and equipment qualification5 years experience in driving supplier performance improvement through CAPA and performing root cause investigation5 years experience in data analysis (capability analysis in minitab, trending/pivot in Excel)5 years experience in supplier development, supplier KPI/performance measurement and demonstrated performance improvementStrong leadership experience Strategic thinker and knowledge of design controls. Project management background preferred Previous Quality engineering experience and demonstrated use of Quality tools/methodologiesExperience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications Ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes, and meets deadlines in timely manner.Strong organizational and follow-up skillsAttention to detail.