Assoc Quality Systems Spec

Location: Tijuana, Baja California, Mexico

Remote Type: Onsite

Time Type: Full time

Job Description

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

We’re looking for a Quality professional to drive compliance, support audit readiness, and lead continuous improvement across quality systems and processes. This role will partner with cross-functional teams to ensure adherence to internal, regulatory, and governmental requirements, while helping standardize best practices and strengthen operational excellence globally.

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.
• Co-ordinates 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.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. 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 and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy: Entry-level individual contributor on a project or work team.
Works with close supervision.

Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems .

Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.

Leadership and Talent Management: N / A – job at this level is focused on self-development .

Required Knowledge and Experience: 

• Bachelor’s degree in Business Administration, Engineering, or a related field.
• 3 years of experience in a similar role.
• Advanced English proficiency.
• Experience with Engineering Change Management processes.
• Knowledge of 21 CFR 820 and ISO 13485.
• Knowledge of Agile and CAPA methodologies.
• Customer service skills.
• Knowledge of Business Process Control (BPCS).
• Advanced Excel skills.
• Experience in Lean Manufacturing and Six Sigma.
• Experience in Project Management.
• Knowledge of Route Analyst.

 

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. 

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Recruitment Fraud Alert 

We are aware of phishing scams targeting job seekers. Please keep the following in mind: 

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. 

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. 

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.
 

 

 

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