The Principal Device Quality Assurance Engineer is an experienced quality and technical professional who develops and has stewardship of the overall device and combination product quality strategy to maximize the benefit and sustainability of Takeda’s in-line products and to bring Takeda’s pipeline products to a sustainable existence on the market.
- Responsible for quality life cycle management of commercialized device and combination products (DCP) to ensure timely release of products and compliant with all cGMP, SOPs, clinical, device, and regulatory requirements
- Accountable for device CAPA, deviation and complaint investigations and incident escalation execution for DCP derived incidents
- Support of post market surveillance activities
- Manage Administration System Qualification (ASQ) projects for Takeda 3rd party and co-packaged devices
- Responsible for driving maintenance and improvement of assigned processes within DCP Quality Management System and support of all appropriate activities in preparation for DCP quality management review
- Responsible for robust 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
- Support activities for clinical evidence review and risk management updates
- Responsible for sustainable device quality assurance support for internal and external manufacturing, packaging, testing and release containing DCP
- Launch readiness activities and regulatory filings
Your Skills and Qualifications:
- Bachelor’s degree of science in engineering or equivalent technical discipline required, and at least 7 - 10 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 5-7 years Quality Assurance and/or Quality Compliance roles
- 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
- Strong background on Medical Device Regulation (MDR) and - Directive (MDD)
- Experience with Class I & II & III sterile and non-sterile medical devices
- Experience with clinical development and regulatory filings
- 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 Good Distribution Practices and global supply and distribution networks
- Experience through interacting and collaborating with cross-functional global teams; project/program management and operational excellence 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.
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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.