Principal Quality Engineer

3 weeks ago

North Haven, United States Medtronic Full time

Careers that Change Lives Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. The Principal Quality Engineer is an individual contributor with responsibility in supporting R&D laboratories in technical functions to advance existing technology or introduce new technology and therapies. This position will partner with laboratories across a global network to drive a quality culture and improvements in day-to-day activities. The Principal Quality Engineer will be a role model and mentor for others on the quality team and work closely with laboratory management to drive change. The position will formulate, deliver and/or manage projects assigned and work with other stakeholders to achieve desired results.

A Day in the Life Responsibilities may include the following and other duties may be assigned. Collaborate with laboratories globally in network to ensure quality standards are in place. Support and champion parts of strategy development and execution. Collaborate with other quality groups across Medtronic. Ensure that corrective measures meet acceptable standards, and that documentation is compliant with requirements. Lead laboratory investigations, root cause analysis and nonconformance reports. Perform audits and provide audit support. Approval of protocols, reports, and testing results. Identify and lead continuous improvement activities in quality processes. Coach, mentor, and review work of lower-level quality engineers and specialists. Must Have: Minimum Requirements Bachelor’s degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality Nice to Have Bachelor’s or master’s degree in chemistry, biotechnology or related field Previous experience in the pharma industry is preferred. CQA and CQE certification is preferred. Knowledge of ISO 17025 Knowledge of ISO 10993 and 21 CFR part 58 is preferred. Previous quality management system experience including root cause analysis, non-conformances and CAPA. Previous experience with internal and external audits as well as conducting internal audits. Ability to work independently under limited supervision to determine and develop approach to solutions. Experience managing projects / processes, as well as coaching and reviewing the work of lower-level specialists. Ability to work collaboratively, exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Recognized expert managing large projects or processes. Adaptability and ability to navigate through change. 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. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.

We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits

here

. The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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