Description de l'emploi
As Software QA Improvement Expert, you will report to the Quality Assurance Director within the Quality, Regulatory & Safety department. Your mission is to ensure that products or services meet the requirements of the IBA Group Quality Policy and the compliance to regulations (ISO 13485, 21CFR, Market Authorizations …).
Your role and responsibilities:
- Support MAS Departments and Business Lines on all elements of software quality assurance to enable manufacturing of a range of product including medical devices. Support encompasses product development, manufacturing operations, information systems and quality systems activities.
- Maintain a working knowledge of software regulatory standards and requirements and provide guidelines to improve Software Quality System procedures representing best practices and GMP.
- Ensure the procedures meet all applicable regulatory, standards and requirements.
- Ensure external and internal quality system requirements are adhered to throughout product and design and development process lifecycles.
- Be a change agent when identifying improvement opportunities, coordinating gap assessment and facilitating changes.
- Contribute to the awareness of the employees on principles of software validation, software risk management and general software quality tools by developing, implementing and improving the related trainings
- A Master degree in computer science, Engineering or related discipline
- Minimum 5 years working experience in Software Quality Assurance, computer science in a regulated industry
- Experience in a managing role for product software validation and software quality assurance activities
- ISO 13485 auditor certification
- Good knowledge of Software Development Life Cycle activities and understanding of software design
- Working knowledge of product software, analytical process software, manufacturing process software and quality system software validation methods and requirements
- Working experience of regulation related to medical device products and software (eg: 21CFR part 820, 21CFR part11, EN ISO 13485, IEC 60601, EN ISO 14971:2012, IEC 62304, IEC 62366) and cybersecurity
- Experience with the CE technical files and 510 (k) dossier submissions
And you are:
- A very committed person ready to inspire a team to move forward
- Able to motivate, support and empower people
- An assertive person with very good interpersonal skills
- A hands-on and proactive person, able to find and propose collaborative solutions
- Good communicator and able to explain good practices and coach people outside your department
- Capable of working autonomously and make decisions
公司IBA : opening new ways in the fight against cancer.
IBA is a cancer diagnostics and treatment company and the worldwide technology leader in the field of proton therapy. The Company’s expertise lies in the development of next generation proton therapy technologies and radiopharmaceuticals that provide oncology care providers with premium quality services and equipment, including IBA’s leading fully integrated IntegraLab® radiopharmacy system, and Dosimetry advanced solutions for Quality Assurance of medical equipment and increased patient safety.
Headquartered in Belgium and employing more than 1,500 people worldwide, IBA currently has installed systems across Europe and the US and is expanding into emerging markets.
The Company is focused on providing solutions in the fight against cancer.
聘用意向书IBA offers you the opportunity to realize great achievements in the fight against cancer. Our employees are perceived as passionate, pragmatic and result oriented people dedicated to develop leading edge technologies to protect, enhance and save lives !
If you are stimulated by multicultural challenges, we offer you the opportunity to join a team of more than 40 nationalities working on more than 45 different sites on 3 continents.
IBA offers you a competitive performance based compensation package and a flexible work environment. You have real possibilities to evolve within IBA's worldwide, leading organization and to create your own career path, supported by training programs to acquire new skills and ensure they stay sharp.
As an Equal Opportunity Employer IBA is committed to a diverse workforce.