Your (new) Opportunity:
- Management of quality life cycle of commerzialized device and combination products (DCP) to ensure timely release of products and compliant with all cGMP, SOPs, clinical, device, and regulatory requirements
- Responsible for device CAPA, deviation and complaint investigations and Incident escalation execution for Device and Combination product derived incidents
- Perform and support post market surveillance activities
- Development, maintenance and improvement of assigned processes within DCP QMS and support of all activities in preparation for DCP quality management review
- Execution of Supplier Quality Management program for DCP suppliers, auditing of suppliers, quality agreements, documentation and governance and management of the quality interface with responsibility for the ultimate release of DCP
- Perform Clinical Evidence Reviews and Risk Management updates
- Management of internal and external manufacturing, packaging, testing and release activites of DCPs
- Support of launch readiness activities and Regulatory filings
Your Skills and Qualifications:
- Bachelor’s Degree Engineering or equivalent technical discipline required, and at least 4 to 7 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 4 years in Quality Assurance and/or Quality Compliance roles
- Knowledge of international regulations for Device and Combination Products with thorough understanding of European, International, and US requirements for Design Control, Supplier Management and Risk Management guidelines, Post Market Surveillance, CAPA, etc. primarily emphasis on ISO 13485:2016, MDSAP, ISO 14971, and 21 CFR Part 4, 820, 803
- Experience with Class I & II & III sterile and non-sterile medical devices
- Experience working with external manufacturing partners; assessing root cause analysis and effective investigation practices; strong operations background to ensure value added and effective quality operations; experience driving out inefficiencies and improving turnaround times; understanding of GDPs and global supply and distribution networks
- Experience through interacting and collaborating with cross-functional global teams
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.369,11 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.