1+ months

Sr Supplier Quality Engineer - Remote within US

Danvers, MA 01923 Work Remotely
Sr Supplier Quality Engineer - Remote within US


Mounds View, Minnesota, United States

Requisition #:


Post Date:

May 27, 2022

**Careers That Change Lives**

In this exciting role as a Senior Supplier Quality Engineer, you will be responsible for the management of our strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) at Medtronic, with accountability to support changes to existing supplied products and processes, as well as oversight of performance and improvement activities. While partnering with our CMs and OEMs, including sub-tier suppliers as required, this position is responsible for maintaining necessary controls and drive improvements relating to finished medical device / component quality in conjunction and within our suppliers quality systems.

You will work in partnership with the internal Medtronic RD, Quality, and Regulatory teams, to deliver ensure our supplied products conform to finished device requirements, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements.

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a trusted partner means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

**A Day in the Life**

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

+ Work with Medtronics strategic CM/OEM suppliers to lead and drive systematic approaches to medical device quality issues.

+ Drive corrective/preventative actions at our CMs/OEMs based on feedback from incoming inspection, production defects, Medtronic/supplier internal quality metrics and customer complaints.

+ Work with sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.

+ Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented.

+ Oversee changes to processes/products currently in production to aid in the correction of process, design or material problems (as well as changes associated with sub-supplier and material changes). Lead quality process improvements and streamlining activities.

+ Lead work with production areas to implement quality-based improvements to current products and manufacturing processes.

+ Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes).

+ Provide technical guidance and quality compliance to suppliers/other resources performing qualification/validation testing.

+ Ensure the resolution of all issues raised during testing/qualification.

+ Instrumental in the development and implementation of systems and processes for CM/OEM supplier management that are in compliance with corporate policies and industry standards/regulations and other quality requirements and guidelines.

+ Supports Corporate and external (FDA, TUV, BSI, etc.) quality and compliance audits of the CM/OEM products and/or the suppliers Quality Management System.

+ Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements.

+ Support / Lead sustaining engineering projects that may involve manufacturing process transfers, label/IFU updates, sub-supplier qualification, performance testing (verification and validation), and design qualification.

+ Participate in the audit/assessment of current or future suppliers/contract manufacturers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements.

+ Position can be remote

**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 and minimum of 4+ years of relevant experience in Engineering and/or Quality OR an Advanced Degree in Engineering, Science or technical field with 2+ years of experience.

**Nice to Have** ( **Preferred Qualifications** )

+ 4+ years experience in Medical Device and/or Capital Equipment

+ Demonstrated working knowledge of supplier controls, process validation, failure investigation techniques, nonconforming product controls, and protocol/report generation

+ 2-4 years experience supporting internal or external manufacturing processes across multiple areas, including, but not limited to: printed circuit board assembly, manual assembly, machining, molding (dip/injection), etc.

+ Project Management experience

+ Quality System Lead Auditor experience (ISO 13485)

+ Use and clear understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)

+ Superb Oral and Written communication skills

+ Ability to work in a team/partnership environment

+ Computer Skills (Microsoft Word, Excel, Project, PowerPoint; Trackwise; Agile)

**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)

Ability to travel up to 15%
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: 2022-05-17 Expires: 2022-07-07

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Sr Supplier Quality Engineer - Remote within US

Danvers, MA 01923

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