R&D Principal Quality Specialist (pharma/API experience required)
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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.
