Principal Quality Systems Specialist - SH&A:
Company: Medtronic
Job Type: Full Time
Location: Hybrid - Santa Rosa, California, United States of America
Posted On: 19 Days Ago
Application Deadline: May 1, 2025
Job Overview:
The Principal Quality Systems Compliance Specialist at Medtronic will be responsible for ensuring compliance with Quality System processes, including external and internal audits, medical device regulations, and requirements. This role involves preparing for audits, conducting internal audits, and providing compliance training to support quality system activities within the Structural Heart and Aortic operating unit.
Responsibilities:
Quality System Compliance: Assess and ensure adherence to Medtronic’s internal policies, FDA regulations, ISO 13485, and Medical Device Requirements.
Audit Preparation & Support: Lead preparations for internal and external audits, including FDA and notified body audits, and participate in audit support roles.
Training & Mentorship: Develop and deliver Quality System compliance training and mentor quality process owners.
Quality System Projects: Lead and participate in quality system projects across multiple sites.
CAPA & Process Improvement: Support CAPA processes and provide guidance on corrective actions, root cause analysis, and process improvements.
Metrics & Reporting: Provide reports on critical aspects of the Quality System’s health.
Other Duties: Perform related tasks as assigned by management.
Basic Qualifications:
Education:
Bachelor's degree or equivalent in a relevant field.
Minimum of 7 years of experience in medical device quality, regulatory, or engineering, or 5 years with an advanced degree.
Experience:
Experience in working with audit findings, corrections, and corrective actions.
Familiarity with FDA regulations (21 CFR 820, 210/211, Part 11) and ISO 13485.
Strong understanding of CAPA programs, project management, and process improvement techniques.
Salary Range:
$124,000.00 - $186,000.00 per year
Benefits & Compensation:
Medtronic offers a competitive salary, a wide range of benefits including health, dental, and vision insurance, 401(k), paid time off, and more.
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