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Sr Operations Quality Engineer Full-time

at Medtronic in Minnesota (Published at 16-01-2020)

Careers That Change Lives

In this exciting role as a Senior Operations Quality Engineer you will have responsibility for the quality of product being produced at the Rice Creek Pharma Operations Manufacturing Site.

CVG 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 resolve quality issues discovered during operations.
  • 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.
  • Conducts quality assurance inspections; and performs statistical analysis to assess whether product meets required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

This position will also:

  • Investigate and resolve quality or compliance issues
  • Ensure valuestream is compliant with internal and/or external specifications, regulations and standards such as ISO.
  • Create and update procedures as assigned, related to the quality system, operations, and product testing.
  • Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.
  • Communicate significant issues or developments identified during quality activities and provide recommended process improvements to team or management.
  • 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.
  • 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, sCAPA or CAPA activities, audit findings, complaint investigations, etc.).
  • Interface and coordinate with other Medtronic facilities to resolve issues and implement best practices.
  • Support internal and external site audits and inspections.
Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelor?s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.

Nice to Have (Preferred Qualifications)
  • Experience with FactoryWorks manufacturing execution system
  • Experience with drug-device combination product
  • Medical device experience strongly preferred

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)

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