[Remote] Design Quality Assurance Engineer II

Note: The job is a remote job and is open to candidates in USA. Candela Corporation is a leading global aesthetic device company specializing in medical and aesthetic laser technologies. The Design Quality Assurance Engineer II is responsible for supporting DQA activities in product development, ensuring compliance with design controls, and overseeing validation processes to achieve product reliability and performance targets.ResponsibilitiesReview and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its complianceProvide support as defined by SOP’s during/after Product Development projectsLead efforts with internal and external stakeholders to resolve all product quality issuesReport, assess, investigate, and conclude/resolve all anomalies/trends in monthly product quality reviews. Lead analysis of post-market data to highlight impactful recommendations for improvement to product quality performanceReview and approval of Product Development Verification & Validation Protocols & Reports (and relevant data) to ensure testing coverage of all product & compliance requirementsApply FDA and other regulatory expertise to risk assessmentsWork with CMOs and supplier quality engineering to ensure appropriate design control mechanisms are in place for design changes and that proper monitoring/control mechanisms are established to ensure all product leaving the factory meets specificationOperate effectively as a team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485 and other national and international quality and regulatory requirements and standardsContribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performanceDevelop statistically sound sampling plans and perform statistical data analysisUnderstand and help implement global processes of the QMS related to Design ControlsWork with product development teams and other QEs to assure compliance to the QMSUse complaints, post market surveillance data, and risk analysis to identify product improvements and provide these as inputs to relevant design activitiesParticipate in Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board ProcessOwnership of risk management process and risk management files. Updated regularly according to QMS and performing ad-hoc risk reviews as necessarySupport of Safety & Compliance testing (IEC 60601) by providing risk and validation documentation and highlighting gaps where appropriateProvide direct support to Regulatory during product submissions by reviewing DHF documents to close submission gaps where possibleOwnership of HRA kick-off process & technical investigations due to adulterated product in the field or safety issuesOwnership of biocompatibility process including the creation of the Biological Evaluation Plan, oversight of ISO 10993 testing where appropriate, and creation of the Biological Evaluation ReportSupport of the External Standards process. Acting as an SME for standards where DQA is directly accountable (ISO 10993, ISO 14971, ISO 11135, ISO 11137 etc.) and participating in gap analysis reviews and action plans as applicableDevelop and oversee the execution of TMV activitiesDevelop and oversee the execution of CSV activitiesRepresent CSV on software development and deployment teams as the software validation subject matter expertEstablish and enforce a Decision Tree for making Validation Change Assessments, and if Validation is required then how the protocol should be constructedPartner with and/or lead business teams and IT to ensure that computerized quality systems are compliant with Candela procedures, FDAs 21CFR11, GAMP 5, and other relevant regulationsAct as a core team member on software validation projects across CandelaMonitor/Review/Approve Sterilization work conducted for Candela’s existing and future products by third party vendors and ensure compliance to current Candela procedures, ISO 11135, and ISO 11137 requirementsCoordinate sterilization qualification for new products and/or changes to existing productsPartner with Candela’s external vendors on sterilization validation for radiation sterilized products including dose setting and quarterly dose auditsPartner with Candela’s external vendors on sterilization validation for ethylene oxide sterilized products including but not limited to new product qualification, annual revalidations, residual EO studiesOther projects as assignedSkillsBachelor's degree in engineering or related field, plus a minimum of 2-4 years of related experience in the medical device or another regulated industryExpert understanding of appropriate global medical device regulations, requirements and standards, including Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820) is a mustExpert level understanding of Risk Management (ISO 14971), Biocompatibility (ISO 10993), and EO/Gamma Sterilization (ISO 11135 & ISO 11137)Working knowledge of IEC 60601, IEC 62366 (HFE), IEC 62304, and IEC 81001-5-1Familiarity with SW and System automated test tools – strong advantageProject Management (development of project plans, status meetings, project reporting, etc) and organizational change movementAbility to analyze information and come to conclusions based on presented dataAbility to communicate effectively both orally and in writingSelf-motivated and ability to manage time working on multiple projects simultaneouslyDemonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems, ServiceMax and Oracle is a plusMust be able to communicate appropriately and adequately to all management levels, including group presentation experienceCompany OverviewCandela’s brand values of Science, Results, and Trust guide its commitment to safety, efficacy, reliability and strengthening the longstanding partnerships of trust established with physicians, their practices and the patients they treat. It was founded in 1970, and is headquartered in Marlborough, MA, US, with a workforce of 501-1000 employees. Its website is http://www.candelamedical.com.