Site CAPA lead (PDF)

Apply for
the job
Jobindex
Site CAPA Lead
Join BK Medical to help develop and maintain quality processes to support the
organization develop our next-generation ultrasound scanners.
This is your opportunity to become part of an innovative team where your
work has a real impact on people’s lives around the world.
Site CAPA lead
Our mission at BK Medical is to change the standard of care in surgical interventions Your professional background:
with real-time visual guidance. You will become part of a true innovator in the
You have a relevant education e.g., as an engineer or other relevant background. It is
MedTech industry with 800 colleagues in Denmark, the United States, and other
crucial that you have experience within a similar role or area for minimum 3-5 years.
locations around the world. Now, we are advancing our mission as part of GE
Furthermore, you have:
HealthCare. This puts us in a position where we can think even bigger and unlock
new opportunities for us, surgeons, and their patients. It’s a great time to join us!
• Extensive experience with NC/CAPA processes
As our new Site CAPA lead, you will join our Quality team of 6 dedicated specialists
• Experience with QA work from the medical device industry
with a mix of seniority and educational backgrounds. We recently expanded the
team, and you will be able to influence the department culture. Our new CAPA site
• Knowledge of ISO 13485, MDR and MDSAP
lead will be responsible for running the NC/CAPA process at our Headquarters in
Herlev. Our QA department supports the organization from R&D to Production, so our • A systematic and analytical approach
daily work has us interacting with colleagues at all levels.
• Good communications skills in Danish and English
As our new Site CAPA lead your typical daily tasks will include:
• Excellent people skills and can convey complex subjects making them
• Running our CAPA review board and providing oversight of the status
comprehensible
• Assist colleagues across the site with their NCs, Investigations and CAPAs in
• The ability to motivate yourself while working independently
Trackwise Digital
• Provide training in both CAPA processes and the tool, Trackwise Digital
Our Headquarters in Herlev are located in a lovely modern building with more than 300
employees. The work atmosphere is casual, and our organizational structure is flat. We
• Performing internal audits
have a good staff canteen focusing on health and variety, private health insurance and
pension plans, as well as social events and several staff clubs.
• Providing input to Quality Management Review
The role requires independency, and you will be in contact with a wide range of the We look very much forward to receiving your application, in which you describe:
organization every day. Due to this you need to be positive, forthcoming, and eager to
1) Your motivation for becoming part of our Quality team
help colleagues to reach our CAPA goals as planned.
2) Your experience and skills that are particularly relevant to this role
For more information regarding the position, you are very welcome to contact
our Director QA, Lene Bastholm: [email protected]
BK Medical is a great place to work. We look forward to hearing from you and
welcoming you to our QA team at our Head office in Herlev.
BK Products Guides Procedures for the Surgeon
Urologist Neurosurgeon HPB Surgeon
Colorectal Surgeon Robotic Surgeon Adjacent Market Users
BK Medical
“By working within these
Global Organization
specialties, I realized that I could
BK Medical is an international company with sales offices all over the world, and European headquarters in
provide or improve the health care
Herlev, Copenhagen.
system that way.”
At BK Medical, we support employees in developing their skills and expertise. We have a professional and
informal organization with flexible working conditions and a flat organizational structure. We are effective
- Rikke von Barm, Specification Engineer
and can execute our ideas into strong products – these ingredients make BK Medical an exciting and
development-oriented workplace.
We look forward to welcoming you to a team that makes a difference – a difference to quality of life.
Intraoperative Ultrasound
BK Medical is committed to designing ultrasound systems that help surgeons image, guide, intervene, and
navigate inside the human body. Surgeons are our customers, and they range from HPB surgeons,
neurosurgeons, and robotic-assisted surgeons to urologists, colorectal surgeons, and more.
Our mission at BK is to enable real-time intraoperative guidance during surgical procedures, giving
surgeons the information needed to immediately make critical decisions. Our products are designed and
customized for surgical procedures to help surgeons save time and get results.
Now, BK Medical is advancing its mission with GE Healthcare. Together, we will reach more customers and
continue to empower surgeons to make critical decisions that allow for better care, faster procedures, and
reduced complications.
As market leaders, we work closely with experts and universities to provide the best solutions to clinical
“I chose to pursue a career in the
challenges.
medtech industry because I want
Research and Development
to work at a place where both the
BK Medical has development departments in Denmark and the US. The largest development team is based
in Denmark. We develop software, hardware, mechanics, signal processing, and advanced algorithms.
company and the colleges always
When it comes to research, we have collaborated with the Technical University of Denmark (DTU) for more
strives for achieving better.”
than 20 years. Together, we have completed 2 high technology projects for advanced ultrasound imaging.
- Rasmus H. Rossen,
We are currently part of a large-scale project with DTU, Danish hospital Rigshospitalet, and the University
Senior Mechanical Engineer
of Copenhagen concerning extreme high-resolution ultrasound.
Apply for the job
Jobindex