We are currently searching for an Engineer with expertise in quality combination products to join an international and fast-growing Biopharma Company.

Client:

• BioPharma company with >20.000 employees, with start-up mindset
• Motivating, and fast-growing environment

Your advantages:

• Competitive salary
• Employer-funded pension
• Global career opportunities
• Flexible working hours and home-office

Position:

• You will assure that the development of medical devices and combination products comply to all regulatory requirements, in alignment with your team and key stakeholders.

• In this position, you should be able to identify Quality issues, as well as initiate corrective measures, using methods such as Lean Six Sigma.

• The development, implementation, and improvement of the quality system for CP/MD complaint and of a global inspection readiness program, will also be part of your responsibilities.

• You will represent your team in cross-functional initiatives, you will take part in external audits and in the development of quality agreements and other activities related with Conduct Vendor Management.

• You will take part in training and mentoring more junior team colleagues and in educating other teams on MD/CP requirements.