Senior Quality Assurance Engineer

at  Elekta

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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!
Senior Quality Assurance Engineer
Job Location: Helsinki, Finland
We don’t just build technology. We build hope for everyone dealing with Cancer.
As a Senior Quality Assurance Engineer, you will act as functional support representing Quality as part of product development teams/projects. With a focus on being the source of knowledge and expertise, you bring guidance and coaching/training on all aspects of Quality System Management and regulatory compliance. You are also an approver of relevant documentation for cross-functional team developing Software medical devices and health IT applications.
This role includes compliance-related activities such as internal and external quality audits, nonconformance/concession/ CAPA management, training of the organization in the quality system, as well as improving and developing ways of working and QMS procedures together with other functions.
What you’ll do at Elekta
Would you like to be part of our driven global team, where we aim to attract and invite the best competences to Elekta? We are offering you an exciting opportunity to join our Regulatory Affairs & Quality Team at Helsinki location, which is currently a team of six team members spread globally.
In this exciting and diverse role, you will represent Quality on internal management meetings, projects, analysing and preparing responses on governing agency actions.

Responsibilities

• Represent the Quality function in projects and processes.
• Responsible for promoting and where assigned, ensuring compliance to the quality management system and regulatory requirements.
• Responsible for escalation of possible compliance issues to the next level of the organization.
• Collaborate closely and communicate effectively with other functional areas of the organization to meet business objectives ensuring regulatory compliance.
• Support processes organization as per agreed assignments.
• Participate in the preparation and supporting external audits by coaching others, and/or as a guide and/or auditee.
• Participate in the preparation and performance of internal quality audits.
• Promote and maintain adherence to Elekta’s values.
• Responsible for decisions that impact the safety and effectiveness of products and services for their relevant area.

What you bring

• Experience and training in regulatory affairs, quality management systems and/or Engineering within a medical device environment.
• Training and/or experience in relevant medical device regulations and standards, e.g. EU MDR, QSR, ISO 13485, MDSAP, ISO 14971, IEC 62304.
• A university degree in Engineering or equivalent in a related field.
• Experience in design and development and risk management, preferably including experience from projects involving medical device software.
• Strong English written and verbal communication skills. Able to work within a multicultural environment.
• High personal integrity, with an ability to interpret, adapt & provide guidance on regulations and translate into meaningful requirements to the business.
• Ability to generate collaborative spirit - An effective team player who prefers to share and communicate problems and solutions with other members of the team.
• Confident and open personality who can communicate effectively, both written and orally with people at all levels.
• Possess a structured approach to problem-solving with an appreciation of quality tools & techniques.
• Understanding of SW development and agile way-of-working.
• Availability for international travel.

Why should you join Elekta?
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. You will be part of our international innovative team and given the opportunity to learn and develop.
Overview of some of our benefits for Finland as below.
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25 paid vacation days/year, additional 2 Elekta days off /year

• Attractive defined contribution pension scheme
• Lunch Benefit
• Contribution to wellness activities
• Occupational Healthcare insurance
• Mobile phone benefit
• Hybrid work option (you are required to work on location at least 3 days/week)

Hiring process
We are looking forward to hearing from you! Apply by submitting your application and resumé in English, via the “Apply” button. Please note that we do not accept applications by e-mail.
Your Elekta contact
For questions, please contact the responsible Global Talent Acquisition Partner, Nidhi Sarkar,
nidhi.sarkar@elekta.com
We are an equal opportunity employer
We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, genetic information, national origin, disability, veteran status, or any other status protected by law in the locations where Elekta operates.
About Elekta
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

• Represent the Quality function in projects and processes.
• Responsible for promoting and where assigned, ensuring compliance to the quality management system and regulatory requirements.
• Responsible for escalation of possible compliance issues to the next level of the organization.
• Collaborate closely and communicate effectively with other functional areas of the organization to meet business objectives ensuring regulatory compliance.
• Support processes organization as per agreed assignments.
• Participate in the preparation and supporting external audits by coaching others, and/or as a guide and/or auditee.
• Participate in the preparation and performance of internal quality audits.
• Promote and maintain adherence to Elekta’s values.
• Responsible for decisions that impact the safety and effectiveness of products and services for their relevant area