Sr Manufacturing Quality Engineer
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors degree in Engineering, Science or technical field with 4+ years of experience in Quality and/or Engineering OR Advanced degree with 2+ years of experience in Quality and/or Engineering.
Nice to Have
· Medical device, pharma or drug-device combination products strongly preferred.
· Experience with FACTORYworks manufacturing execution system.
· Experience in environmental monitoring and qualification.
· Comprehensive understanding of drug cGMPs and ICH Q7.
· Comprehensive understanding of drug GMP facilities, utilities and cleanroom requirements particularly for potent compound APIs.
· Comprehensive understanding of analytical laboratory testing.
· Strong written and verbal communication skills in the English language.
· Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards.
· Working knowledge of statistical methods associated with six sigma and quality control.
· Effective project leader and experience with lean manufacturing principles and their implementation.
· Ability to maintain a professional and respectful relationship with coworkers and company.
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.
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)