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Principal Pharma Quality Engineer

Rice Creek, MN
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  • Job Code
Company Medtronic
Job Title Principal Pharma Quality Engineer
JobId 37584
Location: Rice Creek, MN, USA

Principal Pharma Quality Engineer


Rice Creek, Minnesota, United States

Requisition #:


Post Date:

Mar 26, 2018

Careers That Change Lives

As a member of the CRHF Quality team you would be able to contribute to work directly that impacts lives of our patients. Medtronic, come for a job, stay for a career.

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

The Principal Pharma Quality Engineer will provide quality assurance expertise for the development, site transfer, manufacturing and testing of combination medical device/drug products for the Fridley CRHF (Rice Creek) Pharmaceutical Operations business.

This position will:

1) Provide support to Rice Creek Pharma Ops projects in order to ensure excellence in quality and compliance for components and finished devices, including combination products

2) Interface with other CRHF pharma manufacturing sites

3) Provide support for post-market activities

4) Provide expertise for the continuous improvement of the quality system

5) Investigate and resolve quality or compliance issues

6) Support CVG Manufacturing Supplier Quality department and Rice Creek site objectives

7) Coordinate these activities across all CRHF pharma manufacturing sites.

CRHF seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice and taking action.

Other responsibilities of the job:

•Ensure area 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.

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

•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.).

•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.

•Work closely with Supplier Quality to develop and maintain inspection procedures for materials, components and products to support receiving inspection, manufacturing and development.

•Lead or participate in supplier audits / assessments, ensuring compliance with associated Medtronic policies and QSR / ISO requirements.

•Support internal and external site audits and inspections.

•Perform combination product lot release activities per approved process.

•Approved finished good label issuance per approved process.

•Perform other related duties as assigned.

Must Have: Minimum Qualifications

•7+ years experience in the medical device, pharmaceutical or highly regulated industry.

•7+ years combined experience in Quality/Regulatory, Manufacturing, Design, Continuous Improvement, Sourcing, or Laboratory functions.


Bachelor’s Degree in Engineering, Engineering Management, or Science / Lifescience

Nice to Have

•Work experience with the following: FDA Quality System Regulations, current Good Manufacturing or Laboratory Practices (cGMPs or GLPs), ISO 13485, ISO 9001 standards and/or equivalent.

•Experience understanding proper documentation / quality requirements for a regulated environment

•Experience and knowledge of current Good Manufacturing or Laboratory Practices (cGMPs or GLPs), USP, AAMI, global Quality System Regulations, ISO 13485 or equivalent.

•Experience understanding proper documentation / quality requirements for a regulated environment.

•Experience applying engineering concepts such as design of experiments, risk management, validation, methodical problem solving, and statistical analysis to drive continuous improvement activities.

•Lean Six Sigma Green Belt or higher certification.

•COS or FTQ experience.

•Experience with manufacturing systems such as JDE, FACTORYworks or SAP.

•Experience with LIMS systems such as TriLIMS, MAQS.

•Strong project/program management experience and/or PMP certification.

•ISO 13485 (Medtronic) lead auditor certification.

•Well-developed interpersonal communication, decision-making and leadership skills. Able to work with internal and external customers.

•Ability to work in a collaborative and cross-functional (matrixed) team environment.

•Basic statistical knowledge and application.

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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life 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.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.


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Principal Pharma Quality Engineer

Rice Creek, MN

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