Description de l'emploi
The QA product release associate ensures the final release of assigned IBA products.
(S)he ensures that released products comply with all applicable regulatory requirements and that they are safe and effective.
(S)he helps to develop the quality culture across the organization by showing the added value of Quality Management integrated in the Departments and Business Lines.
- Approve final release of products
- Ensure QA involvement on assigned projects
- Review product & project deliverables
- Review and approve product verification and validation activities needed for final release
- Review and approve non-conformities handling decisions including follow-up of required corrections and corrective actions
- Review and approve product design change activities
- Perform in process quality audits and ensure follow-up of resulting corrections and corrective actions
- Monitor and ensure implementation of the QMS of processes and activities reviewed as part of the release activities. Support its improvement.
- Develop, maintain and improve procedures, work instructions and templates within the area of expertise
- Coach, train and assess training needs of IBA personnel on quality requirements related to release activities
- a Master degree in Engineering/Sciences or an equivalent demonstrated by experience
- at least 2 years of work experience in a regulated environment, in a quality role
- working knowledge of Machinery Directive, Medical Device Regulation, ISO 9001/13485 is an asset;
- excellent communication skills in French and English (spoken and written)
And you are:
- an assertive person with very good interpersonal skills
- able to manage different projects in parallel
- able to work to strict deadlines and to cope with pressure
- rigorous but don’t lose the general picture
- a hands-on and proactive person, able to find and propose collaborative solutions
- a team player
- willing to travel (up to 10%)
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.