Senior Quality Assurance Engineer - Hardware

Please click here to apply through our internal career site Find Jobs - Elekta.

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 don’t 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 www.elekta.com/products/brachytherapy/xoft/.

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 role’s 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 you’ll 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 care.  In 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 résumé 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.