Quality Systems Specialist

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

Medtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value – and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic!

Reporting to the Quality Systems Supervisor, the Quality Systems Specialist will handle the QMS, GMP and PMV operations to ensure the company is operating and meeting the established quality standard of medical devices across all business. This is a rare and incredible opportunity to enhance your skillset in supporting our market leading technology across a broad range of products.

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

• Ensure Korea QMS follows Korea medical device regulation and ISO 13485

• Maintain QMS procedures and quality records to align with global policies, local regulation, and local practice

• Establish training matrix and assign training in learning management system

• Conduct internal audit and corrective and preventive actions

• Prepare and support Post Market Surveillance audit (e.g., Random product inspection, Unannounced surveillance inspection, Special inspection from MFDS etc.)

• Manage distributors and suppliers

• Manage change control and risk management

• Participate and own local/APAC project for continuous improvement

• Handle Product Complaint

• Handle Adverse Event Reporting, Oversee Adverse Event Reporting and Foreign Material reporting

• Execute Field Corrective Action (FCA)

• Collaborate with global complaint and FCA team for Enterprise quality strategy

Required Knowledge and Experience:

• Bachelor’s degree required in medical, biological science or equivalent field

• Prior experience in a Quality Specialist role is essential with 3 - 5 years of relevant experience, preferably medical devices.

• Good understanding and working knowledge of QARA Operations

• Effective written and verbal communication skills in English and Korean languages

• Strong ability to work well within a team and autonomously

• Achievement oriented and ability to drive results with the highest quality standards

• Computer skills (excellent knowledge of MS Office products)

• High attention to detail and accuracy

• Good prioritization and organizational skills

• Excellent problem-solving skills

• Korea Good Manufacturing Practice (KGMP) onsite audit and Medical devices class IV product handling experience is highly regarded

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