Medical Device Quality Manager (m/f/d)

Division Global Drug Development
Geschäftseinheit QA GDD
Standort Holzkirchen (near Munich)
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Temporary
StellenID 262038BR


Stellenbeschreibung

The Medical Device Quality Manager is responsible to manage a portfolio of assigned Medical Device/ Drug Device combination projects to assure cGMP Compliance with medical device specific regulations (ISO 13485:2016, EU MDR and 21 CFR 820) and internal Novartis standards for Sandoz Medical Device development products under submission and Life Cycle Management activities. He/She ensures the quality specific tasks of a Design History File and follow-up including supporting medical device reporting to regulatory authorities.

• Manage a portfolio of assigned Sandoz Medical Device/ Drug Device Combination projects from Quality perspective and provide functional expertise in the area of responsibility for medical devices and combination products in cross-functional project teams.
• Quality responsible person for the assigned Design History File portfolio.
• Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients and represent Medical Device Quality in initiatives and cross-divisional projects.
• Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting.
• Create, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance.
• Perform or support inspections and audits as required and provide support to line functions in GMP compliance related issues in the area of expertise (e.g. Medical Device standards).
• Support project management functions as a sub-team member in preparation for PAI Inspection and critical Quality aspects.
• Periodic Review and Reporting of Compliance Status and Quality Compliance KPIs, CAPAs for assigned projects.



Quality


Mindestanforderungen

• Graduate in Engineering e.g. Medical Device engineering/ Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
• Project Management experience (e.g. PMP)
• English fluent in speaking / writing
• At least 3 years of relevant experience
• Sound scientific, technical and regulatory knowledge in Medical Device area (ISO 13485:2016, EU MDR and 21 CFR 820)
• Ability to influence people, negotiate and communicate
• Experiences with health authorities and notified bodies
• Good compliance knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines
• Good knowledge of medical device compliance for development and life-cycle management
• Excellent organizational and project management as well digitalization skills
• Good and proven ability to analyze and evaluate cGMP compliance


Why consider Novartis?

927 million. That’s how many lives our products touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Sandoz, a Novartis Division. Join us and help reimagine medicine.
We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.

Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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