Quality Engineer Manufacturing

Are you ready to drive excellence in medical device quality at the forefront of active imaging technology? Shape the future of surgical care by ensuring the highest standards in production and compliance.

Elevating quality standards in a world of advanced medical imaging
As a Manufacturing Quality Engineer at BK Medical, you will play a vital role in shaping the future of surgical care. Reporting to the Quality Director, your mission is to uphold and enhance high standards in product and design quality. You will be the driving force behind ensuring compliance and excellence in manufacturing processes. Your responsibilities are diverse and impactful. You will bridge the gap between quality and manufacturing, attending key meetings to provide essential support and insights. You will also be crucial in process control and improvement, involving process validation, risk management, and continuous improvement initiatives. From attending daily Manufacturing "Stand Up" meetings to provide essential quality support, to liaising with the manufacturing department to ensure seamless integration of quality standards in every process. In this role, you will not only oversee but actively participate in the pilot production of new products, ensuring they align with the quality standards. Your involvement in conducting Quality Management system audits will be key to maintaining and elevating the production facility's standards.

Quality visionary in medical device engineering
The ideal candidate will have a strong foundation with a B.Sc. or M.Sc. in Engineering, preferably in Mechanics, Electrical, or Chemistry, or a closely related field. This role requires a professional who brings great experience in a similar capacity within the Medical Devices sector, showcasing a profound understanding of the unique challenges and standards of the industry.

A deep familiarity with regulatory frameworks, particularly ISO 13485, is crucial. The candidate should be adept in controlling procedures in the production area, encompassing risk management, process validations, supplier evaluations, inspection processes, test methodologies, and quality assurance plans. Effective communication is key; fluency in English, both in writing and speaking, is essential for seamless collaboration within BK Medical's global teams.

The role calls for an individual who is not just a problem solver but a proactive thinker, someone who can maintain composure under tight deadlines and pressure as well as the ability to positively influence, train, and coach colleagues. BK Medical is looking for someone who is committed, positive, and focused, capable of prioritizing tasks and collaborating effectively across diverse teams.

Pioneering quality in medical innovation at BK Medical
Step into a role at BK Medical where your expertise in quality engineering directly shapes the future of surgical care. If making a tangible difference in healthcare motivates you, this role is your gateway to a fulfilling career in medical technology innovation. The recruitment process is carried out by Venaris Executive Search (www.venaris.dk). For more information regarding the position, please reach out to Executive Search Consultant Lars Nordlund on +45 3123 3018. All requests will be handled confidentially. If this position is for you, do not hesitate to apply by uploading your CV - it is not necessary to include a cover letter.

BK Medical
BK Medical is a market leader within active imaging and has always been committed to designing systems that help surgeons visualize anatomy and lesions, guide interventions, and navigate inside the human body. BK Medical is an international company with sales offices all over the world, a global headquarter in Boston, Massachusetts (US), a European headquarter located in Herlev, Denmark, and a transducer manufacturing site in State College, Pennsylvania, US. The company employs approximately 700 FTEs globally and 200 FTEs in Herlev. In 2021, BK Medical was acquired by GE Healthcare. With this acquisition, GE Healthcare adds the fast-growing and relatively new field of real-time surgical visualization to GEs pre- and post-operative Ultrasound capabilities, creating an end-to-end offering through the full continuum of care from diagnosis through therapy and beyond. Through significant synergies with the benefit of GEs technology and commercial scale, BK Medical will be able to reach new customers and markets around the world.