R&D Principal Quality Specialist

BELLCO, now part of Medtronic in the Renal Care business, is a company, based in Mirandola (Modena – ITALY), leader in systems for hemodialysis and extracorporeal blood purification. Our therapies and systems are employed for the treatment of renal failure, multiple organ failure, sepsis and cardiac decompensation. We are focused on satisfying the needs of patients and experts through: Innovation, Reasearch, Development of advanced Nephrology, Intensive Care and Cardiology Therapies. The R&D Principal Quality Specialist will use their high level technical and leadership skills to support the development of an innovative product in dialysis. The selected candidate will apply technical principles, theories, and new concepts to collaboratively drive team trough product development. Responsibilities will focus on designs control, regulatory impact, risk management file, project management, failure analysis. The selected candidate will work under the general direction of the core team member for quality and with functional manager for product on field. He/She will be the SME for business unit for Pharma process and API regulations. He/She will participate in cross-functional and cross-site development teams that are responsible for different aspects of the project. The Engineer will interact with a cross-Functional team to define Product requirement, standard and regulation applicable to the project. Main interaction will be focused on: Sourcing • Supplier requirement definition for API a pharma product • Supplier Audit is a Plus RA & R&D • Definition of pharma requirement on products • Definition of applicable regulation on products • Definition of applicable Standard and regulation (process and product) applicable to the product MFG • Definion of manufacturing requirement for API, and medical device • Review of Manufacturing process and risk assessment. The Engineer will guide and train the team on pharma regulation and process. Position Responsibilities • Quality leadership in the development of new products through knowledge of applicable regulation. • Quality leadership on pharma product currently on filed, evaluate complaint trend, support audit. • Review product and process pharma concepts, testing, evaluates results using appropriate statistical analysis tools. • Work with internal and external advisors/leaders to determine product requirements • Work as SME for Applicable regulation and standards for Pharma and API. • Work under direction of core team member and team leader toward pre-determined long-range goals and objectives • Act as advisor and mentor to other engineers and technicians • Apply advanced problem-solving skills, critical thinking Must Have: Minimum Requirements • Bachelor’s degree required • Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience • Knowledge of QSR 21 CFR 820, 803, and 21 CFR 4. • Knowledge of EU MDR and its implication to combinational products (Article 117 amendment to Annex I) •Experience preferably in both Medical Device and Pharma/API Desired/Preferred Qualifications • Bachelor’s degree in engineering / Life Sciences discipline. • Problem solving and strategic planning skills. • An excellent level of English, both written and spoken. • Effective verbal and written communication skills in order to keep other managers and department heads informed on project. • Good interpersonal skills and able to work effectively both in cross-functional teams and independently. • Attention to detail, and capacity to follow projects through to completion. • Experience with International Guidelines (ISPE, ICH, PDA, EU Ph, US Ph) • Experience working directly with FDA and Notified Bodies • Experience interpreting and implementing US and global medical device/pharma regulation • Availability to travel domestically and abroad Travel Expectations: less than 15% of the time Location: Mirandola (MO) About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the future. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe it’s the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law. Join us and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer — your unique perspectives, talents and contributions — we can live up to the promise of our Mission. ...