About the role:
In this exciting and challenging position you will be performing in the department of Research & Development on site in Vienna.
How you will contribute:
Provides Device QA support for Takeda medical devcie and combination products (DCP) to ensure timely release of products. Responsible for device CAPA, deviation and complaint investigations and incident escalation execution for DCP derived incidents.
Support Supplier Quality Management program, auditing of suppliers, quality agreements and new supplier requests.
Supports functionality, maintenance, and further development of the certified Medical Device Quality Management system in compliance with applicable regulations and standards.
Monitoring, collection and reporting of DCP key performance indicators throughout life cycle.
Subject matter expert for assigned DCPs
Participate on teams developing and/or qualifying DCP and responsible for living documents management (risk management, Design Histrory File, Device Master Records, specifications, etc.)
Assessment and investigation of customer complaints
What you bring to Takeda:
Bachelor’s Degree in BS in Engineering or equivalent technical discipline required, or at least 3-5 years of experience working with medical devices and/or combination products in a regulated healthcare industry,
Knowledge of international regulations for Device and Combination Products with understanding of International, and US requirements for Design Control, Supplier Management and Risk Management guidelines, CAPA, etc. primarily emphasis on ISO 13485:2016, ISO 14971, and 21 CFR Part 4, 820, 803.
Knowledge of Medical Device Regulation (MDR)
Experience with Class I & II sterile and non-sterile medical devices
Experience with device lofe cycle manamgement and regulatory filings
Experience working with external manufacturing partners; assessing root cause analysis and effective investigation practices; experience in eliminationg inefficiencies and improving processes.
Experience through interacting and collaborating with cross-functional global teams; project/program management and operational excellence preferred;
Strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to use that information to make scientifically sound Quality risk based recommendations and decisions.
Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as team member, share information and deliver results with a team.
Analysis of product information, implementation of process and product improvements as a result of product knowledge.
Decision-making skills even in times of ambiguity.
Be Positive, Accountable, Results Oriented, An Excellent Manager of Self and Others
What Takeda can offer you:
A competitive remuneration package with a minimum salary of € 3.557,47 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.
Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
Work @ home depending on the position / department
Comprehensive training programs
In-house job rotation program
In-house Canteen with discounts or meal vouchers
Works council (events, festivals, shopping vouchers, etc.)
Employee Referral Program
Employee Recognition Program
Takeda Resource Groups
Free vaccination program
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
AUT - Wien - Industriestrasse 67
Fixed Term (Fixed Term)