Job Information
Takeda Pharmaceuticals Specialist Device Quality Assurance (f/m/d), Fixed Term, Hybrid in Vienna, Australia
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Job Description
About the role:
As the Specialist Quality Assurance you will manage and support Takeda's medical device and combination product life cycle management efforts throughout commercialization until end of life. This position is limited for 2 years in the first step, an extension is possible.
How you will contribute:
Representing DQ (Device Quality) in support of quality life cycle management of commercialized device and combination products (DCP).
Responsible for individually assigned Design Transfer activities of class 1, 2, 3 drug delivery devices and DCP to ensure timely launch and ensure compliance with all cGMP, SOPs, clinical, device, and regulatory requirements.
Creating living documents (risk management, specifications, etc.) of DCPs, co-packaged combination products and procedure packs, coordinating Clinical Evaluation Reviews and Risk Management updates in the course of post market surveillance activities.
Supporting device, DCP and quality improvement initiatives and design improvements within lifecycle management of assigned medical devices or combination products.
Device CAPA, deviation, complaint investigation and incident escalation execution for DCPs, co-packaged combination products and procedure packs derived events.
Prepare and participate internal and external audits including readiness as an SME on DCP life cycle management activities.
What you bring to Takeda:
Completed studies in natural sciences or equivalent discipline (pharmacy, microbiology, processing technology or similar).
2-4 years of experience working with medical devices in a regulated healthcare industry, Quality Assurance and Quality Compliance Experience are very welcome.
Alternatively experience from Quality area from automotive or food industry.
Knowledge of both EU, US and International Device regulatory requirements (specifically Regulation (EU) 2017/745, 21 CFR Part 820, ISO 13485, ISO 14971), and other applicable standards.
Experience with statistical and DMAIC methods, with risk management processes and tools.
Expertise in stakeholder management with external partners for life cycle management.
including batch release, supplier notification of changes and supplier alerts.
Strong analytical skills for product information and driving improvements.
Fluent English and good knowledge of German.
What Takeda can offer you:
A competitive remuneration package with a minimum salary of € 4.157,14 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 (https://www.youtube.com/watch?v=0yl80fFR1hU)
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
Medical checkups
Free vaccination program
Fitness Center
More about us:
At Takeda (https://www.youtube.com/watch?v=eXGvhwALf2A) , 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.
Locations
AUT - Wien - Industriestrasse 67
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time