Senior QMS Lead – Regulatory & CAPA

MiniMed Group; California; On-site; USD 87,000 - 149,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Dental insurance

Vision insurance

401(k) match

Stock purchase plan

Job summary

MiniMed is seeking a Senior Quality Systems Specialist in Northridge, CA to lead and optimize our quality management system across manufacturing, CAPA, supplier quality, and regulatory affairs. You will review changes, drive process improvements, prepare audit materials, and partner with cross-functional teams to ensure compliance with internal policies and external standards.

The role emphasizes data-driven decision making, effective communication, and proactive risk management, with

Qualifications

• Requires a Baccalaureate degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
• Requires experience in Quality Management Systems, including Change Management, Continuous Improvement and CAPA.
• Requires experience in usage of Microsoft Office Suite – especially Word, Excel, PowerPoint, etc.

Responsibilities

• Reviews and facilitates development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance to co-workers in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Supports audit and inspection preparation, resolution of audit and inspection findings through all stages of the audits.
• Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
• Leads or supports compliance related activities like audit readiness, Corrective and Preventative Actions (CAPA), process improvement.

Skills

Quality Management Systems

Change Management

CAPA

Regulatory Affairs

Data analysis

Education

Bachelor's degree

Tools

Trackwise

PowerBI

Project

Excel

Word

Job description

MiniMed is seeking a Senior Quality Systems Specialist in Northridge, CA to lead and optimize our quality management system across manufacturing, CAPA, supplier quality, and regulatory affairs. You will review changes, drive process improvements, prepare audit materials, and partner with cross-functional teams to ensure compliance with internal policies and external standards.

The role emphasizes data-driven decision making, effective communication, and proactive risk management, with