Senior Quality Assurance Engineer
Senior Quality Assurance Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Are you a current Elekta employee
Please click here to apply through our internal career site Find Jobs - Elekta.
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) for Xoft products to meet identified standards regulations and company requirements reporting to the Elekta Inc. Head QA/RA.
The Senior QA Engineer will perform QMS duties such as document control complaint handling corrective/preventive action nonconformance management internal audits support/host external audits support product design projects support RA and escalation to upper management.
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. QMS
Quality Records management of the Elekta Inc. QMS
Implement any new Quality requirements into the Elekta Inc. QMS
Identify and implement process improvements in the Elekta Inc. QMS
Report status and issue escalation to upper Management as required
Manage and/or participate in Elekta Inc. QMS internal and external audits
Escalation of any QMS risks or issues to reporting Manager
Train any employees to QMS related activities
Active participation in QA Projects as directed from the Management Team
Implement any new assignments from reporting Manager
Drive efficiencies within the roles responsibilities
Support activities in accordance with the RAQ overall business plans and in alignment with overall Elekta objectives
On-site QA Representative role to assist other Elekta entity QMS as directed from QA Management
On-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 required
QA Engineering skills and knowledge in a certified CE ISO 13485 and MDSAP medical device industry company
QA Engineering skills and knowledge of various QMS activities such as document control complaint handling corrective/preventive action nonconformance management internal audits external audits
Ability plan host and manage Quality meetings
A structured approach to problem solving with an appreciation of quality tools & techniques
Objective driven and customer focused with an ability to influence people
Capable of producing results working unsupervised under own initiative
An effective team player who prefers to share and communicate problems and solutions with other members of the team
Confident and open personality who is able to communicate effectively both written and orally with people at all levels
Ability to analyze and decide efficiency improvements in QMS and business environments
A positive attitude towards change to promote the global goals of the business
Easy to adapt Quality requirements and flexible to different implementation approaches
High personal integrity and ethics
Excellent English written and verbal communication skills are essential
Expert knowledge of ISO 13485 MDSAP CE and other global quality system standards and regulations
A university technical degree or equivalent and/or a number of years experience in Medical Device Quality Assurance desired
Proficient in Microsoft Office and computer applications to perform role
Ability to work efficiently within a multi-cultural environment
What youll get
In this role you will work for a higher purpose; hope for everyone dealing with cancer and for everyone regardless of where in the world to have access to the best cancer addition to this Elekta offers a range of benefits.
What we offer:
Opportunity to work with a proactive and supportive team
Hybrid work option (you are required to work on location at least 3 days/week)
Excellent Medical Dental and Vision coverage
401k paid Vacation and Holiday
A wealth of additional benefits including wellness reimbursement tuition reimbursement and flexible spending account
Opportunity to work on cutting edge in medical advancement.
Close-knit company culture
Upward 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 sexsexual orientation gender identity genetic information national origin disability veteran statusor any otherprotected characteristic.
The base salary range for this position is $115000 - $135000 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.
Required Experience:
Senior IC
Employment Type
Full-Time
