Quality Assurance Officer

OncoRadiomics is a fast-growing, ambitious company, with headquarters based in Liège, Belgium. Expansion to the US and China are in our plans for the near future. Our mission is to revolutionize patient care and drug development thanks to artificial intelligence and the radiomic features embedded in medical imaging. OncoRadiomics has a CE marked/ FDA pending clinical decision support system (RadiomiX Clinical) as well as a unique research software (The Discovery Toolbox). OncoRadiomics also offers solutions for optimized clinical drug development trajectories to major pharmaceutical companies thanks to its proprietary software and in-house expertise.

OncoRadiomics strives to have a very talented and diverse team as its core asset, next to several international patents. We aim to recruit the right talent for the right position and offer an ambitious and innovative work environment. With the entire team behind the goals that OncoRadiomics has set, initiatives are met with positivity and talent is nurtured. Thanks to the intrinsic talent within the team and warm working relationships, not a day goes by where you will not learn something new from one of your colleagues.

We are currently looking to enlarge our team with an additional Quality Assurance Officer.

Role Summary:

The Quality Assurance Officer is responsible for developing the quality strategies, policies, processes and standards within OncoRadiomics in line with the required industry standards, accreditation requirements and business requirements.

Ambition, passion, ability to learn fast, curiosity and creativity are important ingredients he/she will bring to the party.

Having experience in this role is a plus but not a prerequisite. Junior candidates are also welcome to apply, we will provide you with the necessary training to develop your professional skills as a Quality Assurance Officer.

Your main responsibilities are:

  • Develop, implement and maintain the Quality Management System (QMS)

  • Managing documentation and record maintenance of the QMS

  • Manage the audit program to ensure that all nonconformities raised against certified bodies during audits are effectively corrected and independently verified

  • Embed a culture of continuous improvement throughout OncoRadiomics

  • Lead OncoRadiomics to achieve quality management system targets for customers and business goals

  • Serve as a subject matter expert to guide the company on QA related issues by communicating proactively and effectively with appropriate key stakeholders

  • Provide leadership in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of company operations, processes and products

  • Ensure the Company is kept current with all new quality-related regulatory requirements, and provide guidance to senior management on the implications of any new or updated requirements

  • Adjudicate issues with compliance concerns

  • Act as the subject matter expert for optimization of new or existing products, processes, techniques, procedures or facilities/equipment to ensure compliance with quality criteria

  • Prepare and review QA budget

  • Support the Company’s project teams and assist with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner

  • Liaison with the commercial team to align QA and the regulatory process with the reimbursement process

Your educational background and competences:

  • You preferably have at least 1- 2 years of experience in QA and QMS

  • You have knowledge of certifications in medical devices (ISO13485, CE labels, 21 CFR Part 11, …) and affinity with using software / services as a medical device

  • You are familiar with ICH/GCP

  • Skill in customer facing roles working in a complex technical environment

  • Proficiency with Microsoft Office suite products

  • Ability to effectively communicate in English

  • Previous experience with building QA systems and company-wide SOP system

  • Proven ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs

  • Experience with multiple aspects of the product development (CMC, nonclinical and clinical)

  • Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards

  • Understanding of scientific methods and the ability to interpret and communicate scientific data internally and externally

  • Knowledge of pharma/healthcare industry and marketplace trends for specific clinical applications and/or product knowledge within assigned area 

Your desired characteristics:

  • Strong interest and some knowledge of drug development, digital healthcare, information systems, networking and ICT 

  • Hands-on mentality, you work accurately, and you fit into an innovative environment

  • Ambitious, fast learner, passionate, curious and creative

  • Willing to have a strong impact on cancer treatment by helping pharma companies and clinical professionals embrace new biomarkers in their drug development and decision making

  • Ability to energize, develop, and build rapport at all levels within an organization

  • Strong written and verbal communication and clear-thinking skills with the ability to synthesize complex issues into simple messages 

  • Be pro-active and take initiatives

  • Ability to multi-task in a very fast-paced environment

  • Solutions oriented and pragmatic

  • Robust interpersonal skills, with demonstrated ability to work independently as well as effectively collaborate with peers

What we offer you:

  • Unique opportunity to help shape a high potential start-up active in a leading-edge AI medical field.

  • A challenging and diversified position within a high-potential innovative start-up company.

  • Huge and fast personal growth potential for the successful candidate (i.e. leading a team in a few years).

  • A young, dynamic, leading edge, and multicultural environment.

  • Onboarding, training, and mentorship.

  • Empowerment, accountability, and recognition.

  • An attractive salary package, with bonus schemes, in line with the position responsibilities and your experience.

Feel challenged?:

If you feel challenged by this opportunity and have a team-oriented / self-driven learner mentality, please send your CV and cover letter to hr@oncoradiomics.com 


We look forward to welcoming you into this fast-growing OncoRadiomics team!


Your application and related information will remain strictly confidential.

 

Clos Chanmurly 13
4000 Liège
Belgium

©2019 by Oncoradiomics. - BE 0662.719.440