QA Specialist, Manufacturing, BK Medical / 1784 / 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. BK Medical is owned by GE Healthcare and they are advancing their mission together.

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 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. In this role QA partners internally with R&D, Manufacturing, Engineering, Supply Chain, and other departments. They implement and enforce quality policies and standards in compliance with ISO 13485. Externally with Contract Manufacturers.

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.

QA Specialist for Manufacturing
Innovative products, Medical Devices

Worldwide leading company within innovative Ultrasound
Help surgeons to make critical decisions during surgical procedures
Important QA role and influence within compliance and liaison with Manufacturing

The Challenge

You are willing to make a difference together with ambitious and talented colleagues. You will participate in different projects and as a Partner for Manufacturing drive continuous improvement of process and product quality and performance. You also align local systems with corporate quality management systems. 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.

Your tasks among others are:

Driving compliance to procedures in production area at BK Denmark
Driving and handle CAPA’s, NC’s and ECO’s approvals
Investigating complaints related to production issues
Liaison with Manufacturing on quality related subjects
Attend daily Manufacturing “Stand Up” meetings and provide quality support
Support production engineering in process control, process, validations, trending, process improvement, process training, programs, software control and validations and risk management
Design, install, and evaluate quality processes, sampling systems, using statistical techniques, inspection processes, test, methodologies, and quality plans
Participate in pilot production of new products
Participate in Quality Management system audits of the Production facility

BK Medical offers a position within a dedicated company with good influence and responsibility, where you will be given the opportunity to put your mark on the job. Your contributions will be valued and define how you are going to work in the future.

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, (Mechanics, Electrical, Chemistry) or a similar relevant background combined with minimum 3 years of experience in a similar function within Medical Devices. Hands on experience with several of the following areas: Compliance with ISO 13485, controlling procedures in production area, requirements, specifications, verification/validation, risk management, process validations, supplier evaluations and inspection processes, test methodologies and QA plans.

You are driving improvement and participate in pilot production of new products and participate in Quality Management system audits of the Production facility.

You are a good communicator, positive, and committed. 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 ”1784/ QA Manufacturing” by e-mail to job@besttalent.dk. You can read more about Best Talent on www.besttalent.dk.