Sr. Expert in Risk Management
Location: Schaftenau, Tirol, Austria
We are part of the Risk Management and Control Strategy Department, supporting the medical device development process from concept to market entry.
About the Role
* We require an expert to organize input from internal functions, apply risk management processes, and compile documentation packages for design history files and design master records.
* This role will support the definition of verification and control activities, communicate risks to cross-functional teams, and provide design recommendations.
* The successful candidate will write scientific documents for external partners or registration purposes and interact with health authorities.
* They will also lead the transfer of knowledge to other departments or contractors, including training and on-site support.
* Key responsibilities include providing scientific guidance, fostering knowledge exchange, developing and mentoring associates, and presenting results internally.
* Additionally, they will develop project plans, timelines, and strategies for designated projects from development to cGMP manufacture.
* Collaboration with stakeholders is essential to establish global policies and support audits.
Minimum Qualifications:
* A Master's degree in Engineering or a related field (Mechanical, Process, Electrical, Computer Science, Medical, or similar) or equivalent experience.
* Excellent English language skills are required, with German knowledge beneficial.
* Prior experience in medical device development or the pharmaceutical industry is advantageous.
* Knowledge of FMEA and risk management principles (ISO 14971) is essential.
What We Offer:
We offer a competitive base salary, an attractive incentive program, a modern pension scheme, childcare facilities, learning opportunities, and career growth within the Novartis group.
We are committed to building an inclusive work environment and diverse teams that represent our patients and communities.
If you require adjustments during the recruitment process due to a medical condition, physical disability, or neurodiverse condition, please let us know so we can provide support.