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Sr Manufacturing Quality Engineer

Fridley, MN 55432
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Sr Manufacturing Quality Engineer


Fridley, Minnesota, United States

Requisition #:


Post Date:

Feb 24, 2021

**Job Title: Sr ManufacturingQuality Engineer**

**Req Number: 20000HIE**

**Location: Fridley, MN**

**Careers That Change Lives**

In this exciting role as a Senior ManufacturingQuality Engineer you will have responsibility for quality systems and product quality at the Rice Creek Pharma Operations Manufacturing site.


**The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.**

**CARDIAC RHYTHM AND HEART FAILURE** offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.

**A Day in the Life**

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

Collaborates with engineering and manufacturing functions to investigate and resolve quality or compliance issues discovered during operations.

Ensure value stream is compliant with internal and/or external specifications, regulations and standards such as ISO.

Communicate significant issues or developments identified during quality activities and provide recommended process improvements to team or management.

Provide technical support for laboratory testing in order to ensure root cause analysis of all issues identified by test and investigative results.

Lead and/or participate in corrective/preventive action teams in resolving production, customer and supplier issues (e.g., nonconformances, CAPA activities, audit findings, complaint investigations, etc.).

Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

Interface and coordinate with other Medtronic facilities to resolve issues and implement best practices.

Support internal and external site audits and inspections.

Review equipment and process validations, changes, nonconformances, etc., in order to ensure compliance and assess the impact on product reliability, process capability and compliance status.

Review and approve test method validation and stability plans and reports.

Develops, modifies, applies, and maintains quality standards and procedures for processing materials into partially finished or finished product.

Devises and implements methods and procedures for inspecting, testing and evaluating products and production equipment.

Create and update procedures as assigned, related to the quality system, operations, and product testing.

**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. Lets 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)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2021-02-26 Expires: 2021-05-07
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Sr Manufacturing Quality Engineer

Fridley, MN 55432

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