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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 le