Quality System Specialist.

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

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

- Execution of Complaint Handling activities: Regulatory decisions and regulatory reporting (drafting and submission)
- Execute tasks using Complaint Handling tools/systems (Global Complaint Handling system)
- Ensure closure of regulatory reports with investigation are done timely, consistently and in compliance with regulatory requirements.
- Respond to stakeholder inquiries regarding status of regulatory decisions and reports
- Assist in training new personnel on system activities, including complaint handling, regulatory reporting, and CAPA management
- Monitor regulatory reporting deadlines and ensure all reports are submitted on time to relevant authorities
- Review and verify the accuracy and completeness of regulatory reports before submission
- Participate in CAPA investigations to identify root causes of quality issues and deviations
- Perform activities within the system to document CAPA activities from stakeholders and global operations units
- Monitor adherence to documented processes and procedures outlined in the QMS. Regularly audit processes to identify any deviations or non-compliance issues and take corrective actions as necessary
- Participate in projects, process improvement initiatives & respond to stakeholder’s additional requests
- Review complaint information and assess if the complaint is reportable to the appropriate regulatory bodies
- Participation in tech/automation initiatives of the organization to improve the overall process of Vigilance
- Consistently learns and adapts to different regulatory requirements and changes of different regions
- Support establishment of quality specifications and standards and support the development of processes and standards.
- Facilitate update of quality documentation, process mapping, reviewing processes and assisting with change initiatives
- Prepare reports, analyze data to identify trends and opportunities for improvement related to the process
- Escalate high risk incidents to management and PMV team
- Respond to both Internal and External Audit enquiries in a timely manner and ensure follow-up on action Items to address any audit recommendations
- Observe all health and safety policies and procedures and take all reasonable care that actions or omissions do not impact on the health and safety of others

Required Knowledge and Experience:

- Bachelor's Degree Required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline
- Fluent English level
- Minimum of 2 to 3 years of experience in Post Market Surveillance, Vigilance or QA/RA role
- MS Office Suite
- At least 3 years of quality experience in the medical device industry or similar environment is an advantage
- Good understanding of GDP and its implementation is required
- Sound awareness and knowledge of ISO 13485 and its implementation
- Complaint handling and Post Market Vigilance experience is an advantage
- Strong experience and knowledge in regulatory requirements for adverse event reporting for approved devices is a great advantage.
- Experience in writing comprehensive regulatory reports is an advantage

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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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).