Senior Quality Assurance Engineers Innovative products, Medical Devices, BK Medicals/ 1779/CLOSED

The Company
BK Medical is committed to designing ultrasound systems that help surgeons image, guide, intervene, and navigate inside the human body. Surgeons are BK Medical’s customers, and they range from HPB surgeons, neurosurgeons, and robotic-assisted surgeons to urologists, colorectal surgeons, and more.
Their mission at BK is to enable real-time intraoperative guidance during surgical procedures, giving surgeons the information needed to immediately make critical decisions. BK Medical’s products are designed and customized for surgical procedures, to help surgeons save time and get better results.

As a market leader, BK Medical works closely with experts and universities to provide the best solutions to clinical challenges.

An open-minded environment
BK Medical supports employees in developing their skills and expertise and have a professional and informal organization with flexible working conditions and a flat organizational structure.
BK Medical’s employees are effective and can execute ideas into strong products – these ingredients make them an exciting and development-oriented workplace.

The Organization and Team
Quality Assurance, Ultrasound Direct is a part of the RA/QA function belonging to the global organization with offices in Herlev, Denmark and the Global Headquarter in Boston, Massachusetts, US. Quality Assurance engineers are engaged in projects to plan and support development of compliant documentation for new products.

QA work closely together with R&D which is located in Denmark, as well as Clinical and Commercial Marketing, Marketing Communication, Product Strategy and Operations. The team is quite diverse and comes from many different cultures. They share great respect for each other and are really good at solving challenging tasks. They value being open minded, professional, trustworthy, honest, and communicating with one voice. They are business oriented and take pride in guiding the organization in the complex QA and Regulatory environment. English speaking people are welcome.

Senior Quality Assurance Engineers
Innovative products, Medical Devices

Worldwide leading company within innovative Ultrasound
Important QA role and influence within R&D projects
Help surgeons to make critical decisions during surgical procedures

The Challenge
You are willing to make a difference together with ambitious and talented colleagues. You will participate in different projects as Senior QA Engineer for Quality & Regulatory compliance. As a company with very high expectations to Quality and Regulatory compliance, you are committed to excel in an environment with these important focus areas.

BK Medical offers an exciting job in an international company with great influence and responsibility. Your contributions will be valued and define how you are going to work in the future.

Your tasks among others are:

Facilitate and develop QA plans for R&D projects
Facilitate Risk Management process
Facilitate Usability process
Responsible for having a compliant technical documentation for products pre and post launch
Review of requirements, specifications, verification/validation protocols and reports, traceability matrices, process validations, supplier evaluations, biological evaluations, clinical evaluations, reprocessing/sterilization, and other documents required
Signs off on ECO’s and DEV´s

BK Medical offers an exciting position within a dedicated company. You will be given the opportunity to put your mark on the job and many opportunities for personal and professional development. Since BK Medical experience growth, there will be good career opportunities within the organization. You will report to the Director of Quality.

Your Talent
You have a relevant education like B. Sc./M. Sc. in Engineering, or a similar relevant background combined with minimum 3 years of experience with focus on product development or quality. Experience in design controls for Medical Devices and hands on experience with several of the following areas: ISO 13485, ISO 14971, IEC 62366, ISO 60601, requirements, specifications, verification/validation protocols and reports, traceability matrices, process validations, supplier evaluations and other documents required for product registrations.

You are used to be working with Project Management and Regulatory Approvals where you are responsible for the progress within the projects.

You are a strong communicator, self-motivated, positive, and committed. You think business oriented and have the ability to organize and plan your tasks. It is important that you are focused, can prioritize, and keep calm when deadlines are tight. You are good at solving problems and thrive in a busy environment. You are comfortable to train, facilitate and coach your colleagues when meeting deadlines for quality activities.

You are fluent in English, both written and spoken. In other words, you have a desire to support and enrich BK Medical’s culture. You appreciate to work in a worldwide leading company, where knowledge sharing, and mutual professional respect makes it fun and meaningful to work.

Application
Best Talent is responsible for the recruitment process at BK Medical and review your application on a confidential basis. Forward your application including your CV in Danish or English marked ”1779/ QA”
by e-mail to job@besttalent.dk. You can read more about Best Talent on www.besttalent.dk.