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Senior Quality Assurance Specialist

Company: Akesis
Location: Concord
Posted on: May 6, 2021

Job Description:

Job Description POSITION DESCRIPTIONSupport to establish, implement and maintain the the Akesis Quality Management System (QMS) for compliance with 21 CFR part 820, ISO 13485: 2016 and other applicable regulatory requirements; as well as QA oversight during product development, pre-production, commercial production and post production activities.ESSENTIAL DUTIESWrite SOPs and work instructions in accordance with all applicable regulatory requirements and internal policies and practicesReview and approve Quality RecordsDevelop and deliver Quality System training on assigned topicsProvide support for FDA inspections, ISO and other international regulatory auditsPerform internal and external (supplier) auditsRepresent QA on new product development teams to ensure compliance to pertinent regulatory requirements and internal proceduresDocument and support with the resolution of product Customer Complaints in a timely mannerSupport with Document Control responsibilities including maintenance of the electronic document management system (eDMS) as well as hard copy Quality RecordsGenerate Management Review data in a manner that facilitates decision making on the effectiveness of the QMS.Provide periodic reports to management on the performance of the QMS against agreed KPIs, and make recommendations to ensure continued effectivenessProactively facilitate timely closure to Akesis Corrective and Preventive Actions including from CAPAs, MRB, internal and external audits, Management Reviews, Customer Complaints, etc.Perform robust Device History Record (DHR) reviews in accordance with established procedures for final product releaseOther duties as assigned based on business needsWorking RelationshipsBe solutions orientated and customer focused at all timesFoster a strong right first time compliance cultureEstablish sound working relationships with co-workers and supervisors through effective communication and collaborationRelevant Knowledge, skills & competEncies -To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.Bachelor s Degree in Engineering or equivalent education and experienceA minimum of 5 years experience working in the medical device industry in quality related roleLead Auditor ISO 13485 certificationKnowledge of Arena Solutions PLM or comparable QMS software and project Management would be a plusPhysical Requirements (Physical demands & work environment)The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job. The incumbent must be able to perform this job safely, without endangering the health or safety of him/herself or others.Will spend substantial time standing, sitting, speaking and listeningMay spend time driving personal vehicle for business-related purposesEQUIPMENT AND SOFTWARE OPERATIONTelephone, cell phone, fax, emailComputer, printer and related equipmentComputer software including Microsoft Office Suite, Internet Explorer, Database softwareAudio visual equipmentCompany Description At Akesis, we innovate precision technologies providing the necessary tools for clinicians in Radiation Medicine to deliver non-invasive treatments and help alleviate the burden of cancer in patients lives.Through the dedication of our employees & partners globally, we will continuously improve the efficacy and affordability of those tools, because patients everywhere deserve access to the best treatment for cancer. Associated topics: process, prevention, quality, quality assurance engineer, quality assurance lead, software quality, software quality assurance, software quality engineer, test, test engineer

Keywords: Akesis, Concord , Senior Quality Assurance Specialist, Other , Concord, California

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