Supplier Qual Engineer II.

Medtronic; Tijuana; Presencial; MXN 360.000 - 600.000; Jornada completa

Descripción de la vacante

Medtronic is seeking a Supplier Quality Engineer II in the Mexico region to ensure supplier parts, materials and services meet quality standards. You will qualify suppliers, monitor manufacturing inputs, and drive GMP compliance across NPD and post‑market activities.

The role requires a Bachelor’s in Engineering with 2+ years in medical device supplier quality or related fields, plus strong knowledge of QA tools, ISO 13485, and cross‑functional collaboration in English/Spanish.

Formación

• Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
• Experience in medical device supplier quality environments preferred.
• Proven ability to apply quality tools and drive continuous improvement.

Responsabilidades

• Ensures suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and administers a Certified Supplier Program.
• Monitors parts from acquisition through manufacturing and resolves supplier-related issues.
• Develops and prioritizes an auditing schedule to ensure GMP compliance and quality standards.
• Evaluates supplier performance and provides feedback for process improvements.

Conocimientos

Quality assurance

Supplier quality

GMP knowledge

Project management

Six Sigma / DFSS

English/Spanish communication

Educación

Bachelor's degree in Engineering or related field

Master's degree (advantageous)

Herramientas

DOE

MSA

SPC

ISO 13485

Descripción del empleo

About Medtronic

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Supplier Quality Engineer II Responsibilities may 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.

Pre-Market Supplier Quality responsibilities

• 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.

Nice to Have (Preferred Qualifications)

• Bachelor’s degree in Engineering, Science, or technical field with 3+ years’ experience in Medical Device OR Advanced degree in Engineering, Science or technical field with 1+ years of experience in Engineering or Quality.


• 2+ years of supplier quality experience in the medical device industry or related field with supplier quality management experience.


• Experience supporting manufacturing processes including printed circuit board assembly, manual assembly, machining, molding (dip/injection), etc.


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


• Project Management experience.


• First Time Quality (FTQ) Coach or Six Sigma / DFSS / Lean Green Belt Quality System Lead Auditor experience (ISO 13485).


• Working knowledge of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control).


• Strong Oral and Written communication skills (English and Spanish).


• Ability to work in a team/partnership environment.

TECHNICAL SPECIALIST CAREER STREAM

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

• Autonomy Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.


• Organizational Impact Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.


• Innovation and Complexity Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.


• Communication and Influence Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision‑making.


• Leadership and Talent Management May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience

Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life‑changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning.

Equal Employment Opportunity

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. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [e-mail] To request removal of your personal information from our systems please email [e-mail]