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Quality Engineer II

4 months 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.

A Day in the Life

The Quality Engineer II - Chemistry will be an individual contributor with responsibility in technical functions to advance existing technology or introduce new technology and therapies. The position will formulate, deliver and/or manage projects assigned and work with other stakeholders to achieve desired results.

Responsibilities may include the following and other duties may be assigned.

* Develop, modify, apply, and maintain quality standards and protocol for processing materials into partially finished or finished materials product.* Collaborate with Global Laboratory Services functions to ensure quality standards are in place.* Ensure that corrective measures meet acceptable reliability 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 efficiencies and simplifications in quality processes.

Must Have: Minimum Requirements

* Bachelors degree required* Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have

* Bachelor's or master's degree in chemistry or related field.* 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.* CQA certification is preferred.* Knowledge of ISO 17025 and ISO 10993 is preferred.* Experience with chemical characterization, reusable device cleaning, ethylene oxide residual, FTIR or Karl Fischer titration testing.* 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.

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) #J-18808-Ljbffr