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San Diego, CA 92154
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Job Details

Prin Supplier Qual Engineer


Tijuana, Baja California, Mexico

Requisition #:


Post Date:

Nov 23, 2020

**Careers that Change Lives**

The **Principal Supplier Quality Engineer** is
responsible for transfer and support of finished Medtronic product at Contract
Manufactures (CM) and Original Equipment Manufacturer (OEM) site.The
Principal Manufacturing Engineer will work as a team member with the
Manufacturing, RD, Sustaining Engineering, Procurement, and Contract
Manufacturing Organization to ensure the successful transfer and ongoing
production of finished Medical Devices at Contract Manufacturers (CMs). Based
in Mexico this position will focus on the projects that are involving CM/OEM

**RCS (Renal Care Solutions) Operatingunit**

Care Solutions (RCS) provides life sustaining therapies globally to patients
suffering from renal failure due to a variety of comorbidities. Renal
Care Solutions is situated within the Minimally Invasive Therapies Group
(MITG), RCS has a strong growth trajectory with an ever-expanding footprint in
one of the worlds largest and fastest growing therapy markets.


+ Facilitateand co-ordinate with CMs to develop, implement, and maintain technical deliverablesassociated with design transfer, MSAs, component qualifications (PPAP), Processvalidations, Quality Plans, Control Plans, and FMEAs

+ Act as the Champion for CTQ, PFMEA, PPAP (componentqualifications), MSA, Control plans, CAPA, and NCR processes.

+ Well versed with ISO 13485, 21 CFR 820.70 and 21 CFR820.30 requirements

+ Develop,implement, and monitor CM performance management, SCARs, compliance, supplieraudits, CM certification and process improvements.

+ Facilitate customer complaints investigations at CM and ensurescorrective actions are taken by CMs

+ Manageall technical aspects of the ECO and SCR processes into the ContractManufacturing organization

+ Translate engineering, manufacturing, and quality requirements forCM products

+ Manage qualifications of changes and co-ordinates associatedchange control activities

+ Candidatemust have the ability to work independently and be able to communicateeffectively with team members.

+ Ability tomeet at off hours in support of Contract Manufacturers located across theglobe with global time zone differences.

+ Define receiving inspection requirements as required andassociated test method validation for all internal Medtronic Test Methods.

+ Demonstrate strong problem solving, influencing, projectmanagement, change management, analytical, and leadership skills.

+ Lead teams and collaborate with multiple levels andcross-functional areas for effective project execution


+ BachelorsDegree in an Engineering/Scientific/Electronic or technical field

+ Minimum of 3-5years of experience working in the medical device manufacturing

+ 7 years of relevant experience

+ Englishlanguage proficiency


+ Well versedin ISO 13485, ISO 14971, 21 CFR 820.70 and 21 CFR 820.30 regulations

+ Experiencewith process validation, inspection and test method validation such as MSA,process control chart, quality assurance procedures and statisticalanalysis

+ Excellentdata analysis skills, and proficient in the use of statistical tools inproblem solving

+ Knowledge ofplant operations and production ramp-up preferred

+ ISO 13485 CertifiedLead Auditor preferred

+ 6 Sigmaand/or Lean experience preferred (trained or certified)


+ Mastery ofmedical device quality systems and applications is preferred

+ Demonstratedability to work successfully in complex and emerging markets, leveraginginterpersonal, communication, and technical skills to optimize results

+ Self-starter,with the ability to work independently and with all levels of managers,associates, and clients

+ Caneffectively lead Change Management efforts

+ Excellentoral/written communication skills

+ Stronganalytical and statistical problem-solving tools

+ Mastery of officesoftware programs - Microsoft Word, PowerPoint, Excel, PLM, Minitab

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

**Nice to Have**

**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)
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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