qc manager to Occlutech International AB in Helsingborg

Job description
Join Occlutech International for a new role, being one of the key players in ensuring the quality of their products and projects for congenital defects, stroke prevention and heart failure! Here you get the chance to be part of one of the of the world´s leading suppliers in the area of structural heart disease. This is a role with important responsibilities and lots of opportunities for personal development. To succeed and thrive in this role you should fit well into Occlutech Internationals values of being a highly motivated individual inspired by making a difference in patients’ lives. If you are a team player with excellent interpersonal, communication and leadership skills and have a strong sense of ownership you might be the right person for Occlutech. Welcome to an exciting work place with dedicated people on a mission to improve the lives of people with heart diseases.

Responsibilities
Occlutech’s products are implanted in tens of thousands of human hearts every year. Quality and consistent performance of the products are key to the trust of thousands of physicians who use their products. Quality is key to Occlutech´s long-term success and they will never compromise it. In this new role you will lead a small team of two QC analysts and you will report to Susana Mogensen, Global Head of Regulatory and Quality and placed in Helsingborg.

Below are some of your responsibilities described in more detail. 
• Identifying, collecting and reporting information related to the performance of the QC process (and other processes as identified) in regular intervals for management review.
• Conducting in-process inspections of production activities in support of production planning and timelines.
• Proactively identifying issues and taking actions to correct.
• Ensuring all staff work in compliance with GMP rules.
• Ensuring that the records associated with inspection activities are properly completed and filed as required.
• Participating in (global) quality meetings as needed.
• Management of equipment requiring calibration (in cooperation with Jena QC office).
• Management of Nonconforming Product, including identification, documentation, segregation and disposition/release according to established procedures. 
• Release batches after final packaging and incoming inspection.

Working hours
Full-time. Start day as agreed.

Qualifications
To be able to succeed and be happy in the role, below qualifications are mandatory:
• Diploma, certificate or other evidence of formal education in pharmacy, engineering or another relevant scientific discipline. 
• At least one year of professional experience within quality management systems or within regulatory affairs relating to medical devices.
• At least one year of leadership experience.
• Knowledge of MDR.
• Knowledge of ISO 13485.
• Fluent in English, both spoken and written.
• Knowledge of Swedish, both spoken and written.

You are a problem solver that sees the big picture, you learn new knowledge quickly and are able to use current knowledge in flexible ways. You are quick to change your behavior to adapt to changing circumstances and you are enthusiastic and positive, even in tough situations. Furthermore you independently initiate activities and projects, within and beyond the scope of your own job. In addition to this you are a good communicator that convey information with clarity and ease and you listen effectively and keep other informed as long as possible. As a leader the most useful traits will be that you are trustful, taking great duty and responsibility, a team player and that you are able to take fast but smart decisions.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
Last day for application is 2020-11-17, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information about the recruitment process: contact Emelie Lanner, Recruitment Consultant at Randstad Life Sciences at emelie.lanner@randstad.se or 072-9733382.

About the company
Occlutech was founded in Germany in 2003, and has since developed into one of the world´s leading suppliers in the area of structural heart disease with products and projects for; congenital defects, stroke prevention, and heart failure.
The company´s products are sold in over 80 countries globally and the total number of implantations is approaching 100.000, setting the highest standards regarding quality, outcomes and patient safety. Occlutech maintains direct sales and clinical support operations to hospitals and physicians in Canada and Europe. Throughout the rest of the world the company works through qualified distribution partners, many of them shareholders and long-term partners. Occlutech operates R&D and manufacturing facilities at its original site in Jena, Germany and at an additional site in Istanbul, Turkey. From Helsingborg, Sweden the company runs its global marketing support, customer service and manages global sales.