Martin Böhm

Quality Management Representative for medical device QMS of Baxter AG (now part of Takeda). Management of medical device QMS according to ISO 13485:2016, 21CFR820, MDSAP. EU authorized representative and person responsible for regulatory compliance according to MDD/MDR for global Takeda. Combination Product, procedure pack and CMO Management.

Quality Management Representative for medical device QMS of Baxter AG (now part of Takeda). Management of medical device QMS according to ISO 13485:2016, 21CFR820, MDSAP. EU authorized representative and person responsible for regulatory compliance according to MDD/MDR for global Takeda. Combination Product, procedure pack and CMO Management.

Quality Management Representative for the medical device business unit of Baxter AG (part of Shire) in Vienna. Management of device QMS according to ISO 13485:2016, 21CFR820, MDSAP. Combination Product and CMO management.

Leading Team for qualification of Administration sets, co-packaged with therapeutics (co-packaged combination products) Development of single entity combination products for Biosimilar programs Process owner for device design control and device risk Management Life cycle management for all co-packaged medical devices

Deployment of Quality by Design and Risk Management Processes (ICH Q8, Q9, Q10 & Q11) Management of QbD / RM activities for Multi site products Mentoring / Facilitation / Training of global product development Teams Computerized System Owner for the Baxalta Risk Management Software (Stature).

Process owner and trainer for Design Control and Risk Management processes for medical devices Coach for global development teams of medical devices Support of due diligence activities in the course of company acquisitions.

Planning and execution of design verification and design validation activities for medical device development Projects Development of risk management files including risk analysis and FMEAs Development of Quality Agreements for contract manufacturers

Management of material life cycle Team for starting materials Execution of material qualifications Monitoring and improvement of key processes within Receiving & Inspection, e.g. material release, material qualification, complaints Project Management, e.g. test reduction

Release of incoming materials Development of test programs and specifications Performing supplier Audits Processing of non-conformances and complaints

Development of a bacterial vaccine against lyme disease. Method development (FACS, SDS Page, Biacore, etc.) Cell culture techniques

Quality System Management according to ISO 9001 and ISO 13485.

Anorganische Chemie, Organische Chemie, Analytische Chemie, Verfahrenstechnik