Quality Systems Spec - Tijuana, México - Medtronic

Medtronic

Empresa verificada

Tijuana, México

hace 3 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

**Careers that Change Lives
**A Day in the Life
Responsibilities may include the following and other duties may be assigned.

Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
Coordinates legal requests in support of government investigations or litigations.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

**Must Have: Minimum Requirements

Bachelors degree required
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have

Bachelor's degree in Engineering Industrial or similar
Experience minimun of 2 years relevant
Advanced Statistical Technique
Excellent English written and oral communication skills.
Strong interpersonal skills.
Knowledge of the industry regulations and ISO standards.

Preferred Requirements:

Data analysis experience
Quality System knowledge
Two years experience within Supplier Quality
Four years experience within the medical device/pharmaceutical industry.
Experience with quality tools and process improvement techniques.
Experience with Agile database management or other ITrelated skills

Essential Functions:

Serve as a vital resource for Supplier Quality Assurance team maintaining a Global Approved Supplier List (ASL). This includes adding suppliers to the ASL per Medtronic's 019 Purchasing Controls and maintaining these suppliers to ensure compliance. Additional responsibilities are shown below.
Subject matter expert on Purchasing Controls, ASL & supplier file requirements; advises sites outside of normal responsibilities.
Qualifies suppliers according to company standards.
Resolves supplierrelated problems as they occur.
Provides technical guidance and quality compliance for Supplier Quality peers.
Collaborates with site representatives to add new suppliers for new products.
Has a large Medtronic wide network to get people in touch with the right people quickly.
Monitors supplier files to identify risks
Supports site during internal and external audits including front room MAP support.
Supports multiple sites adding new suppliers in Agile and creating the file structure architecture.
Owns TrackWise Task PRs to address supplier file noncompliance.
Coach peers through the 019 process when needed.
Support site specific projects when needed.
Participate in Supplier Quality activities and special projects.

**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.

Let's 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)