
Quality Systems Specialist
Are you passionate about ensuring quality and compliance in the medical device industry? Do you have a keen eye for detail and a strong understanding of quality systems? Medtronic is seeking a dedicated and driven Quality Systems Specialist to join our team. In this role, you will play a critical role in maintaining and improving our quality systems to ensure our products meet the highest standards of safety and efficacy. If you have a strong background in quality systems and are committed to making a difference in the lives of patients, we want to hear from you.
- Develop and maintain quality systems to ensure compliance with regulatory requirements and industry standards.
- Conduct audits and assessments of quality systems to identify areas for improvement.
- Collaborate with cross-functional teams to establish and maintain quality processes and procedures.
- Monitor and track quality metrics to identify trends and potential areas of concern.
- Implement corrective and preventive actions to address quality issues and prevent recurrence.
- Stay up-to-date on changes in regulations and standards related to medical devices and update quality systems accordingly.
- Conduct training and provide guidance to team members on quality systems and compliance requirements.
- Lead and participate in quality system improvement projects.
- Ensure timely and accurate documentation of all quality activities.
- Support product release and post-market surveillance activities by reviewing and approving quality documents.
- Participate in external audits and inspections as needed.
- Communicate with suppliers and internal stakeholders to resolve quality issues and drive continuous improvement.
- Engage in risk management activities to identify and mitigate potential quality risks.
- Champion a culture of quality and compliance within the organization.
- Continuously assess and improve quality systems to meet the evolving needs of the medical device industry.
Bachelor's Degree In A Relevant Field Such As Quality Assurance, Regulatory Affairs Or Biomedical Engineering.
Minimum Of 3 Years Of Experience Working In A Quality Systems Role In The Medical Device Industry.
Knowledge Of Fda Regulations, Iso Standards, And Other Applicable Quality System Requirements.
Strong Attention To Detail And Ability To Analyze Data To Identify Trends And Areas For Improvement.
Excellent Communication And Interpersonal Skills, With The Ability To Work Collaboratively With Cross-Functional Teams.
Risk Management
Quality Assurance
Process Improvement
Data Analysis
Auditing
Quality Control
Root Cause Analysis
Quality Management Systems
Regulatory compliance
Training and Development
Documentation management
Communication
Conflict Resolution
Leadership
creativity
Organization
flexibility
Teamwork
Adaptability
Problem-Solving
Time-Management
According to JobzMall, the average salary range for a Quality Systems Specialist in Minneapolis, MN, USA is between $55,000 to $75,000 per year. However, this can vary depending on the specific company, level of experience, and other factors such as education and certifications. It is important to research and compare salaries for this role at specific companies in the area to get a more accurate range.
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Medtronic plc is the world's largest medical device company that generates the majority of its sales and profits from the US healthcare system and is headquartered on the island of Ireland.

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