Senior Quality Assurance Engineer Hardware Job at Elekta in San Jose

Overview

Are you a current Elekta employee?Please click here to apply through our internal career site .Want to join a team with a mission to improve and save lives?We continually look for motivated and skilled individuals who are interested in supporting our customers healthcare professionals who use our products to help patients and their communities.We currently have the following opportunity available please contact us for more details!We dont just build technology. We build hope for everyone dealing with cancer.The Senior QA Engineer will support participation and maintenance of the Elekta Inc. Quality Management System (QMS) located in San Jose CA for Elekta Xoft products to meet identified standards, regulations and company requirements reporting to the Elekta Inc. Head QA/RA. Elekta Xoft products are Brachytherapy oncology treatment hardware systems referenced in .

Responsibilities: The Senior QA Engineer will be the on-site QA Representative in the Elekta Inc. San Jose USA facility to support the QMS (Xoft products)Be a source of knowledge, expertise, and guidance of the Elekta Inc. QMS.Maintain procedures, work instructions and templates in the Elekta Inc. QMSQuality Records management of the Elekta Inc. QMSImplement any new Quality requirements into the Elekta Inc. QMSIdentify and implement process improvements in the Elekta Inc. QMSReport status and issue escalation to upper Management as requiredManage and/or participate in Elekta Inc. QMS internal and external auditsEscalation of any QMS risks or issues to reporting ManagerTrain any employees to QMS related activitiesActive participation in QA Projects as directed from the Management TeamImplement any new assignments from reporting ManagerDrive efficiencies within the roles responsibilitiesSupport activities in accordance with the RAQ overall business plans and in alignment with overall Elekta objectivesOn-site QA Representative role to assist other Elekta entity QMS as directed from QA ManagementOn-site QA Representative role to assist the IT Dept. for the ISO 27001 Certificate activities within the San Jose facility

What you bring Minimum of 3 years in a medical device industry or regulated manufacturing facility Senior QA position is requiredQA Engineering skills and knowledge in a certified CE, ISO 13485 and MDSAP medical device industry companyQA Engineering skills and knowledge of various QMS activities such as document control, complaint handling, corrective/preventive action, nonconformance management, internal audits, external auditsAbility plan, host and manage Quality meetingsA structured approach to problem solving with an appreciation of quality tools & techniquesObjective driven and customer focused, with an ability to influence peopleCapable of producing results working unsupervised under own initiativeAn effective team player who prefers to share and communicate problems and solutions with other members of the teamConfident and open personality who is able to communicate effectively, both written and orally with people at all levelsAbility to analyze and decide efficiency improvements in QMS and business environmentsA positive attitude towards change to promote the global goals of the businessEasy to adapt Quality requirements and flexible to different implementation approachesHigh personal integrity and ethicsExcellent English written and verbal communication skills are essentialExpert knowledge of ISO 13485, MDSAP, CE and other global quality system standards and regulationsA university technical degree or equivalent and/or a number of years experience in Medical Device Quality Assurance desiredProficient in Microsoft Office and computer applications to perform roleAbility to work efficiently within a multi-cultural environmentWhat youll get

What we offer: Opportunity to work with a proactive and supportive teamHybrid work option (you are required to work on location at least 3 days/week)Excellent Medical, Dental and Vision coverage401k, paid Vacation and HolidayA wealth of additional benefits including wellness reimbursement, tuition reimbursement and flexible spending accountOpportunity to work on cutting edge in medical advancement.Close-knit company cultureUpward mobility

How to proceed?We are looking forward to hearing from you! Apply by submitting your application and rsum in English, via the Apply button. Please note that we do not accept applications by e-mail.We are an equal opportunity employer.We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.The base salary range for this position is $115,000 $135,000, depending on experience.Here at Elekta, you will make a difference. We are a MedTech company that provides software and hardware to hospitals and clinics all over the world.We have a responsibility toward our partners and customers to deliver solutions in a secure and sustainable way. Both when it comes to financial and environmental matters, but also for our employees to feel that they bring value, wherever in the organization they may work.

Elekta

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