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Sr Pre-Market Supplier Quality Engineer

Mounds View, MN 55112
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Sr Pre-Market Supplier Quality Engineer


Mounds View, Minnesota, United States

Requisition #:


Post Date:

Jan 11, 2021

**Careers That Change Lives**

In this exciting role as a Senior Pre-Market Supplier Quality Engineer you will have responsibility for CM/OEM premarket project support in the Cardiac Surgery and Structural Heart product portfolio. Responsible for product acceptance, test method validation strategy, and issue management with accountability to support selection, approval and qualification of new suppliers/OEMs. Ensure proper supplier controls are implemented in support of DRM and flawless launch initiatives. Lead the oversight of premarket products, ensuring conformance to purchased materials or finished devices requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations.


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.

**CORONARY AND STRUCTURAL HEART** provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

**A Day in the Life**

+ Represent the organization as the primary CM/OEM technical contact, at times requiring coordination between organizations and functions.

+ Review and approve CM/OEM change requests and partner with Sourcing Engineering to develop and implement appropriate strategies to qualify and support the change approval process. Could include IQ/OQ/PQ/pfMEA

+ Own/develop technical solutions to problems using the corrective/preventative action process.

+ Analyze and identify trends from quality data/complaints and develop proactive measures with suppliers/OEMs in support of continuous improvement

+ Maintain Medtronic supplier audit schedule and lead or participate in the audit/assessment of current or future suppliers, ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements

+ Participate in the successful completion of supplier excellence programs and, as required, functions in a project leadership role

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

+ Ensures that suppliers deliver quality parts, materials, and services.

+ Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.

+ Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.

+ Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.

+ Evaluates suppliers internal functions to assess their overall performance and provides feedback in assessment of their operation.

+ Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.

+ Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods. Extended member of product development team working in close liaison with the Quality CTM.

+ Responsible for execution of test method validation for all Internal Medtronic Test Methods at Receiving Inspections to satisfy both regulatory and internal Medtronic requirements, including the preparation of high quality protocol and reports.

+ Collaborate with CE Engineer to develop the Receiving Inspection Develop Product Acceptance Sampling Strategy for New Products.

+ Responsible for the creation of new Supplier Control Plans.

+ Initiate Non-conforming documentation, propose and approve component dispositions.

+ Co-ordinate the addition of New Suppliers to the Approved Supplier Listing (ASL) to support NPD.

+ Performs timely investigations into supplier quality issues which had resulted in a Supplier escape, PHO, Field Complaints, Field Actions, including coordinating material disposition, CAPAs, SCAPAs and Inspections.

+ Supports Quality Engagement with Sourcing for technical rigor independent approvals.

+ Anticipate roadblocks, provide direction for navigating the quality system and supporting applications. Work in a cross-functional, collaborative, team-based environment; work with multiple sites in various locations and time

+ Serve as a technical resource for problem investigations; Support failure analysis of any product failures and associated corrective actions using both internal and external resources to guide root cause analysis and corrective action development.

+ Applies understanding of statistical concepts in conduction of validations.

+ Effect continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen. All activities must be performed in compliance with the Quality System.

+ Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts). Implement corrective and preventative actions.

+ Make timely decisions related to product and process quality; determine appropriate project plan when complete information is unavailable

+ Assess, provide recommendations, and lead implementation of systems, processes and equipment for improvement and compliance to Good Manufacturing Practices at suppliers to ensure safe and effective products are produced. Provide written reports and supporting documentation for recommendations.

+ Work with a high level of autonomy under minimal supervision.

**Must Have: Minimum Requirements**

+ Bachelors Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality

**Nice to Have**

Experience in a regulated industry, preferably Medical Device.

Experience in a pre-market environment

**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)

Travel 10% as regulation allow
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: 2021-01-14 Expires: 2021-03-22
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Sr Pre-Market Supplier Quality Engineer

Mounds View, MN 55112

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