Quality Assurance Professional
hace 4 días
About Us
Medtronic is a global leader in medical technology and solutions. Our mission is to alleviate pain, restore health, and extend life for millions of people worldwide.
We are a learning culture that values innovation, collaboration, and teamwork. We strive to make a positive impact on the lives of our patients and customers.
A Day in the Life
As a Quality Systems Specialist, you will be responsible for developing and maintaining quality programs that ensure compliance with regulatory requirements and internal policies.
Your key responsibilities will include:
- Developing and implementing quality management systems processes, including document control, corrective and preventive action, supplier and distributor management, and compliance.
- Providing expertise and guidance on interpreting policies, regulations, and internal guidelines to ensure compliance.
- Collaborating with subject matter experts across the globe to implement quality management systems processes.
- Working with operating entities to provide process analysis oversight and enforce requirements.
- Supporting audit and inspection preparation, resolution of findings, and liaising with auditing groups and inspectors.
- Preparing reports and documentation for stakeholders, both internal and external.
Requirements
To be successful in this role, you will need:
- A bachelor's degree in engineering, quality, or a related field.
- Minimum 2+ years of relevant experience in quality system specialist roles or equivalent.
- Excellent communication skills, fluency in English and Spanish (writing and speaking).
- Strong knowledge of MS Office, Excel, and computer systems.
- Previous experience leading programs and projects for quality functional groups.
- Quality management or document control experience.
- Familiarity with FDA and regulations.
- Audit and compliance experience.
- Corrective and preventive action (CAPA) experience.
- Technical writing experience.
Estimated Salary: $85,000 - $110,000 per year
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