Clinical Laserthermia Systems AB (CLS) develops and markets therapies, systems, and single-use instruments for gentle and safe thermal treatment of solid cancer tumors. The TRANBERG®|Thermal Therapy System, as well as disposable materials and methods, for heat-induced immunotherapy enables safe and gentle treatment of cancerous tumors. The products are marketed for image guided laser ablation and for CLS’ own immunostimulating therapy, imILT®.

Today, our products (i.e. The TRANBERG®|Thermal Therapy System and disposable materials) are commercially available and routinely used in focal therapy of localized prostate cancer. Treatment of tumors and other lesions in the brain as well as abscopal treatment of metastasized cancer comes next. Our targeted customers are hospitals involved in multidisciplinary cancer treatment.

The use of imILT is currently restricted to clinical investigations only and the clinical effects when applying the imILT protocol are being investigated. Our clinical studies are carried out in cooperation with European KOLs and include cancer in breast, liver, lung, pancreas, prostate, and skin.

For patients, imILT could provide extensive medical benefits since the treatment is expected to produce lasting immunity (comparable to vaccination) against the treated form of cancer. In addition, the number of side effects associated with traditional therapy such as surgery, radiotherapy and chemotherapy can be reduced if some of these procedures are replaced by imILT. In summary, imILT entails decreased cancer-related suffering and socioeconomic savings through more effective therapy, with lower expenses for both inpatient care and outpatient follow-up care.

Targeted user groups include medical specialists in surgical oncology and oncologic interventional radiology. Letters of intent are signed with four hospitals with the objective to make these reference centers in Europe for imILT. They will play a key role in market expansion and to facilitate adoption of imILT into routine clinical use.

The Company is headquartered at Medicon Village in Lund, Sweden, with subsidiaries in Berlin, Germany, in Boston, USA and in Singapore. Today, there are 19 employees (Lund 11). CLS is listed on Nasdaq First North Growth Market.

For more information about the company, please visit
http://www.clinicallaser.se

 

TILLSATT - QA Project Manager/Engineer



Company:
Clinical Laserthermia Systems AB (CLS)
Role: QA Project Manager/Engineer
Reporting to: Director QA/RA
Place of position: Lund, Sweden


Profile
Clinical Laserthermia Systems (CLS) is now implementing a new eQMS (CANEA ONE). The solution will ensure simpler and more efficient handling of e.g., documents, deviations, CAPAs and change orders.

We are now looking for a QA Project Manager/Engineer who will be the application manager for the eQMS. The role is to take care of the system throughout its life cycle and ensure that it creates benefits in the business. Solid experience from project management with agile working methods is an advantage, preferably in medical technology with IT systems. These are the most important responsibilities, as the system owner:

• Responsibility for the application
• Define strategies to maximize the operational value of the application
• Manage information pertaining to the application or related IT solutions
• QA tasks related to CAPA, CO and QMS

CLS is looking for a committed, independent, and thorough person to take on the role as QA/RA Coordinator/Manager. This role has an important supporting function at the company, to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.

You will lead the handling of complaints, any recalls and deviations, CAPAs and Change orders. Excellent communication and collaborative skills are important as the role involves many contacts, mainly internal but also external. You are goal- and result-oriented, and you have a structured way of working and enjoy working in teams. The role involves support of the quality system, quality-related documentation, continuous improvements as well as participation in internal audits.

As a person, you are structured and thorough, with great drive and a high sense of service. You have a good understanding of the business and are motivated by finding and developing cost-effective and optimal solutions. Furthermore, you are unpretentious and flexible, with an ability to work for the company's overall needs.

As the company is small, you must have a “can do” attitude and be comfortable in situations where you are hands-on. Integrity and an independent character are highly valued personality traits and should be combined with the ability to effectively collaborate with others. The position is based at Medicon Village in Lund, Sweden and you will report to the Director QA/RA.


Key responsibilities
• Act as super-user of company’s electronical management system CANEA ONE
• Perform trouble shooting/problem solving for quality system topics
• Work with project team and be responsible for QA-related issues within the project
• Coordinating efforts related to audits, reviews, and examinations
• Follow up relevant quality improvement activities implementation
• Review and approval of relevant quality documentation
• Monitor and coach Document Control operation
• Support with statistics and documents for Quality Review Board and Management Review meetings
• Assist Management Representee to handle the activities of ISO13 485 system and applicable regulations of medical devices
• Participate in all stages of product, process, method and instrument validation/qualification and validation of IT processes
• Coordinate and maintain the Validation Master Plan
• Participate and lead all stages of Nonconformance, Change Control and Corrective and Preventive Action (CAPA) procedures
• Interact with Technical Department and Sales in e.g. development projects to ascertain that applicable Technical Documentation is written correctly
• Support the Technical Department with e.g. review of instructions for use, validation documents from test laboratories
• Follow-up of quality documentation at CLS subsidiaries
• Maintaining compliance of CLS’s Technical Documentation in applicable markets


Required Qualifications
• MSc in natural sciences, systems engineering or equivalent
• Experience from quality management system preferably in medical device industry
• Good experience of agile working methods
• Industrial project management experience from structuring flows and processes
• IT skills, proficient with Microsoft Office products
• Fluent in English, both oral and written


Skills and Personal Competences
• Collaborative skills - establishes good relationships with people inside and outside the organisation
• Excellent verbal and written communication, structures information to meet the needs and understanding of the intended audience
• Demonstrates a rapid understanding of newly presented information
• Well structured - plans activities and projects well in advance and takes account of possible circumstances
• Works productively in a high-pressure environment


Opportunities with the role
This is an opportunity to work together with a dedicated team in a rapidly growing company, with short decision-making processes where each employee's contribution is important for the company's development and results. You will be a part of a dynamic, skilled, collaborative and ambitious team with an open and pleasant atmosphere. Here is innovation and high drive important factors for the company’s development and results.


Contact
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.

catharina.herbertsson@peaksearch.se, +46 (0)70 615 27 72
eva.runnerstrom@peaksearch.se, +46 (0)70 172 53 79
http://www.peaksearch.se


Application
Apply for the position at PeakSearch homepage http://www.peaksearch.se or send your cover letter together with your CV directly to either Catharina or Eva, see above.