Your new Opportunity:
The Device Product Lead is an experienced Quality and Technical professional who executes the overall device and combination product quality strategy to maximize the benefit and sustainability of Takeda’s commercial products and to bring Takeda’s pipeline products to a sustainable existence on the market.
- Support quality life cycle management of commercialized device and combination products (DCP) to ensure timely release of products in compliance with all regulations, SOPs, clinical, device, and regulatory requirements
- Execute/approve device CAPAs, deviations, complaint investigations, vigilance assessments, and incident escalations for DCP derived incidents
- Maintain Design History Files (DHF), Risk Management Files (RMF), Device Master Files (DMR), and Technical Files based on events and post market surveillance reviews
- Support maintenance and improvement of assigned processes within DCP QMS and support all appropriate activities in preparation for DCP quality management review.
- Ensure robust Supplier Quality Management program for DCP suppliers, including auditing of suppliers, quality agreements, documentation and governance and management of the quality interface with responsibility for the ultimate release of DCP
- Providing sustainable Device QA support for internal and external manufacturing, packaging, testing and release of DCPs. Perform batch release for DCP
- Drive launch readiness activities and support regulatory filings
- Participate on teams sustaining and/or improving DCP and developing global policies and procedures for DCPs
- Monitor and analyzes DCP quality performance to demonstrate levels of control, capability, and compliance
- Locations: Austria or Lexigton (MA) USA
Your Skills and Qualifications:
- Bachelor’s Degree in BS in engineering or equivalent technical disciplines
- Minimum of 5 years of experience working with medical devices and/or combination products in a regulated healthcare industry within Quality Assurance, Quality Engineering and/or Quality Compliance
- Expert knowledge of international regulations for device and combination products with full 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 with clinical development and regulatory filings
- Experience through interacting and collaborating with cross-functional global teams; project/program management and operational excellence preferred
- Green Belt or Black Belt certification; Auditor certification highly preferred
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 € 4.439,- 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.
AUT - Wien - Industriestrasse 67