QA Compliance Expert Medical Device (f/m/d), Quality, Kundl, Austria
160 Million! This is the number of antibiotics packs that we produce in Kundl and deliver to patients in more than 80 countries all over the world in a year! Your role will be to ensure that the site maintains alignment with the local legislation (AMBO), EU directives and FDA guidelines.
As QA Compliance Expert Medical Device you will provide leadership and ensure that all aspects of the operational business and Quality Management System pertaining to Medical Devices comply with international regulations and standards. You will also ensure that all medical devices manufactured by site or by external supplier in addition to the imported products for local site are released to the market according to our Quality Standards and ensure appropriate oversight of combination products.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• QA oversight of Medical Device and Combination Product suppliers including design and development, manufacturing, and distribution
• Assure that Quality Manual and associated procedures / SOPs and training conform with applicable standards and regulations (e.g. MDR, ISO 13485, 21CFR820) for Combination Products & Medical Devices throughout the product life cycle
• Be the contact person for Notified Body regarding QMS and surveillance audit coordination
• Review and approval of relevant regulatory documentation and Design History File documents for commercial products
• Ability to fulfill requirements / act as Person Responsible for Regulatory Compliance (PRRC) according to European Medical Device Regulation (EU MDR 2017/45)
• Ability to fulfil requirements / act as Medical Device Management representative according to ISO 13485 §5.5.2 and 21 CFR Part 820.20(b)(3)
• Support change control and compliance activities for Medical Devices & Combination Products including post market surveillance, vigilance, annual review etc.
• Provide technical expertise ensuring quality and compliance for Medical Devices and Combination Products
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you'll bring to the role:
• Master's or Ph.D. degree in natural sciences or engineering
• Subject Matter Expert for Medical Devices with a minimum 4 years of experience in Device QA e.g. Quality Management System oversight, Supplier Oversight and Control Strategy, hands-on experience with Combination Products and Medical Devices
• Detailed understanding of product processes for combination products and medical devices including relevant regulations and standards e.g. EU MDR 2017/45, ISO 13485, ISO 14971, 21CFR820 and Part 4
• Proficient in English and German
• Ability to communicate complex information clearly across functions to drive smart decision making at expert and leadership level
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 66.526,88 EUR /year (on a full time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network