Quality Systems Specialist

Medtronic; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

A leading healthcare technology company is seeking a skilled professional to lead and manage their Quality Management System (QMS) processes. This fully remote position primarily focuses on ensuring compliance with ISO 13485 standards while driving continuous improvement initiatives across global teams. The ideal candidate should have a strong background in quality processes, project management, and relevant programming skills.

Benefits

Competitive Salary

Flexible Benefits Package

Short-term Incentive Plan (MIP)

Qualifications

• Fluent in English.
• Three years’ experience in a quality role in the healthcare industry.
• Lead or Internal Auditor certification in QMS (e.g., ISO 13485 or GMP) preferred.

Responsibilities

• Manage change controls and monitor key quality metrics.
• Coordinate cross-functional teams for project execution.
• Support self-inspections and audits.

Skills

Python

Microsoft Platforms

Power BI

Education

Bachelor’s Degree in life science

Job description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life The position offers a dynamic opportunity to support and evolve a Regional Change Control and the QMS process within the healthcare industry, ensuring compliance with ISO 13485 and GxP standards. The responsibilities of the position include the management of the change controls, the training of teams, manage projects for the QMS, the monitoring of key quality metrics, and the implementation of automation to streamline processes. The ideal candidate will possess expertise in Quality processes, project management, and will be able to work cross-functionally with the different global teams to drive continuous improvement.

Additionally, it would be preferable for the candidate to possess a strong foundation in Python, Power BI, and Power Automate. The position is entirely remote and is based in Colombia; therefore, it is not necessary to travel.

Responsibilities may include the following and other duties may be assigned:

• Support and document KPIs related to the monthly Audit/change control/QMS objectives. Also, must provide mitigation, correction, and improvements plans in case of unaccomplished with the KPIs targets
• Coordinate cross-functional teams to ensure successful project execution.
• Provide guidance and experience in interpreting policies, regulations and procedures to ensure compliance
• Support the process of self-inspections, Change Control, internal and external audits, participate in the resolution of the findings to the applicable QMS
• Lead and participate in projects within the Audit/change control/QMS processes and Automation
• In case of acting as an owner for documents or processes must assure that all activities related are updated and aligned with QMS applicable requirements

Required Knowledge and Experience:

• Bachelor’s Degree in life science
• Fluent in English
• Three years’ experience in a quality role in the health care industry with a high focus on ISO 13485
• Python, Microsoft Platforms, and Power Bi skills
• Lead or Internal Auditor certification in QMS. (eg ISO 13485 or GMP) and working knowledge of ISO 13485 is advantageous

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.

Learn more about our business, mission, and our commitment to diversity here