Global Quality Systems Lead (QMS, CAPA)

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

MiniMed invites applications for a Senior QMS Specialist who will partner with Manufacturing, CAPA, Supplier Quality, Audit and Regulatory Affairs to ensure adherence to quality systems and regulatory expectations. You will drive QMS changes for product and process releases, build relationships across the organization, and support audits, CAPA, and process improvements.

A Bachelor’s degree with 7+ years (or an advanced degree with 5+ years) in quality or a related field is required, along 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

• Review and drive QMS changes to support product and process releases and updates, sourced from local and enterprise level.
• Build and maintain positive relationships across the organization with strong relationship skills and act as a quality partner to other groups.
• Coordinate with team members, manager and other stakeholders to support both day-to-day activities and long‑term goals.
• Contribute to QMS quality by identifying, collaborating, creating and/or completing process improvements changes.
• Support monthly and quarterly quality metric reviews (as well as others) by facilitation, communication, review and recording.
• Use critical thinking and data analysis to identify outliers or concerns and act to resolve.
• 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.
• May act as back‑up for software validation or other quality activities as needed.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Skills

Quality Management Systems

Change Management

Continuous Improvement

CAPA

Microsoft Office Suite

Education

Bachelor's degree

Advanced degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

MiniMed invites applications for a Senior QMS Specialist who will partner with Manufacturing, CAPA, Supplier Quality, Audit and Regulatory Affairs to ensure adherence to quality systems and regulatory expectations. You will drive QMS changes for product and process releases, build relationships across the organization, and support audits, CAPA, and process improvements.

A Bachelor’s degree with 7+ years (or an advanced degree with 5+ years) in quality or a related field is required, along with