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Principal Supplier Quality Engineer - Acquisitions

Northridge, CA 91325
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Principal Supplier Quality Engineer - Acquisitions


Northridge, California, United States

Requisition #:


Post Date:

Nov 03, 2020

**Principal Supplier Quality Engineer Acquisition Integration**

**Northridge, CA (Los Angeles, CA)**

**Careers That Change Lives**

The Principal Supplier Quality Engineer will partner with Medtronics suppliers, and their respective suppliers, processes,and systems to prevent defects, and allow us to provide our customers with the highest quality and most reliable products.

This role will be working with Contract Manufacturers (CM), acquisition integration activities and new product introductions.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Principal Supplier Quality Engineer will manage all aspects of tier one, and where necessary sub-tier, supplier quality activities for assigned suppliers/commodities; drive quality and process improvement at assigned suppliers/commodities.

Assess, monitor, and ensure the continued adequacy and effectiveness of the quality system for the assigned supplier base. Support supplier selection, supplier process validation/controls, and general supplier development. Review and approve inspection sampling plans or drive source inspections for select parts. Assume special assignments to drive internal or supplier processes or address critical commodity and/or supplier concerns.

The Diabetes Group is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes, so people with diabetes can, enjoy greater freedom and better health.

Visit to see an overview of the products in our Diabetes product portfolio.

**A Day in the Life**

+ Establish and successfully execute supplier management plans which will align to overall business objectives

+ Improve material quality by ensuring proper inspection methods and drawing requirements are communicated, understood, and deliverable by our suppliers and perform source inspections where necessary.

+ Perform thorough supplier audits and assessments of their processes and QMS and drive improvement.

+ Update suppliers records, and supplier performance metrics, produce supplier reports and drive improvements.

+ Conduct MRB reviews (In-process/WIP and incoming) and initiate proper corrective action and effective supplier feedback.

+ Collaborate with supplier development by evaluating and developing supplier processes through process and product and/or tooling validations and provide assistance, conduct supplier review meetings and supplier training.

+ Demonstrate knowledge of national and international requirements and standards such as FDA QSR Part 820, ISO14971, ISO 13485, ISO 9001, and others as applicable.

+ Statistical Analysis - Have a basic understanding of and ability to apply statistical concepts, SPC/SQC, Continuous Improvement, Trending, Process Capability, MSAs and DFX concepts.

+ Knowledge/basic understanding of specification development, industry standards, geometric dimensioning and tolerancing (GDT), etc.

+ Metrology Concepts Knowledge of inspection/measurement methods and technology

+ Ensure the proper validation of supplier processes and test methods

+ Provide Manufacturing, Quality, and other departments with timely investigations into supplier quality issues, including coordinating material purges, participating in CAPAS and Inspections.

+ Assist by writing and revising policies and procedures, and creating forms to support our supplier development processes.

+ Implement real-time work in process (WIP) and failure tracking process at supplier sites.

+ Establish component level ongoing reliability testing (ORT) at factory and drive quality improvement if required.

+ Correlate and standardize test and inspection processes as required.

+ Drive failure analysis and corrective actions/supplier corrective action requests (SCAR) within assigned suppliers/commodities.

+ Manage first article inspection process along with measurement system analysis (MSA), component qualification, and process validation including manufacturing process verification if required

+ Own and maintain supplier part control/process management plans

+ Approve supplier manufacturing/test/inspection plans and procedures

+ Impose the supplier product/process change management process

+ Ensure accurate and complete preparation of supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, supplier audits/approvals, incoming inspection planning, and other miscellaneous quality documentation and records

+ Support new supplier development and commodity team strategies

+ Participate in design reviews with the development teams

+ Automate supplier data collection and reporting; support any score-carding activities

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.

+ Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.

+ Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.

+ 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.

**Must Have: To be considered for this role, the following minimum requirements must be evident on your resume.**

Bachelors degree in Engineering or Scientific field with 7+ years of work experience in engineering and/or quality OR a Masters degree in Engineering or Scientific field and 5+ years of work experience inengineering and/or quality.

**Nice to Have**

- 8+ years of directly related experience in a Supplier Quality Engineering role, strongly preferred.

- Experience working with Contract Manufacturers, Acquisition Activities and New Product Introductions, strongly preferred.

- Experience working in the medical device, biotechnology, automotive, aerospace or pharmaceutical industry

- Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV)

- Prior experience with electrical, chemical, plastics, mechanical, and/or electro-mechanical commodities

- Advanced degree (MS and/or MBA), Masters degree in Engineering or Scientific field with an emphasis in Engineering,

Materials, Quality Assurance, or Quality Systems

- ISO 13485 Lead Auditor Certification

- Experience with polymers, plastics and injection molding is highly desirable

- Knowledge with PPAP/high volume process and part validation techniques

- Knowledge of the Medical Device regulations (21 CFR 820 and ISO 13485)

- ASQ certified quality engineer (CQE) and/or black belt certification

- Ability to work with minor guidance and under pressure

- Ability to drive and deliver innovative, effective and timely solutions as well as mentor others in best practices and

industry standards where applicable

- Low Cost Country/Asia/Europe experience combined with high tech/med-high volume processes

- Effective verbal and written communication skills in order to effectively communicate with internal customers and

suppliers, and to develop and present communication plans and strategies. Must be a team player.

**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)

**Domestic and international travel up to 50%**
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: 2020-11-05 Expires: 2021-04-16
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Northridge, CA 91325

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