Senior Quality Systems Specialist

MiniMed•Northridge, CA

5d•$87,000 - $149,000

About The Position

MiniMed is seeking a detail-oriented, proactive Senior Quality Systems Specialist with a strong foundation in quality regulations and standards, the ability to manage competing priorities, and communication skills to engage effectively across the organization. The role partners with stakeholders in Manufacturing, CAPA, Supplier Quality, Audit, and Regulatory Affairs to align quality systems with regulatory expectations. The specialist reviews and drives QMS changes supporting product and process releases and updates, contributes to quality process improvements, supports quality metric reviews, and uses critical thinking and data analysis to identify and address concerns. The position also supports the development and maintenance of quality programs, systems, processes, and procedures; provides guidance on policies and regulations; supports audits and inspections; prepares reports and documentation; and leads or supports compliance activities, including audit readiness, CAPA, and process improvement. The specialist may provide backup for software validation or other quality activities and helps maintain consistent standards and share best practices globally.

Requirements

Baccalaureate degree and at least 7 years of relevant experience, or an advanced degree and at least 5 years of relevant experience.
Experience with Quality Management Systems, including Change Management, Continuous Improvement, and CAPA.
Experience using Microsoft Office Suite, especially Word, Excel, and PowerPoint.

Nice To Haves

Mastery of a specialty area and knowledge of industry practices, typically obtained through advanced education combined with experience.
Medical device industry experience and relevant regulatory and standards knowledge; strongly preferred.
Direct experience in Audit Backroom and/or Front Room roles, non-product computer system validation, regulations and standards assessment, translation coordination, and/or multi-site or QMS entity coordination.
Broad knowledge of project management or process improvement methodology.
Six Sigma, Kaizen, PMP, or other project management certification.
Experience with software systems such as Agile, Trackwise, Microsoft Teams, Project, or PowerBI.

Responsibilities

Review and drive QMS changes supporting product and process releases and updates, including changes sourced locally and at the enterprise level.
Communicate and collaborate effectively using strong verbal and written communication skills.
Build and maintain positive relationships across the organization and act as a quality partner to other groups.
Coordinate with team members, the manager, and stakeholders to support day-to-day activities and long-term goals.
Identify, collaborate on, create, and complete quality system and process improvements.
Facilitate, communicate, review, and record monthly, quarterly, and other quality metric reviews.
Use critical thinking and data analysis to identify outliers or concerns and act to resolve them.
Review and facilitate the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance and conformance to internal and external standards and guidelines.
Provide expertise and guidance to coworkers interpreting policies, regulatory or governmental regulations, and internal regulations.
Work with operating entities to provide ongoing process analysis oversight and support compliance with requirements and regulations.
Support audit and inspection preparation and resolve findings through all stages of audits and inspections.
Prepare reports and necessary documentation for applicable internal and external stakeholders.
Lead or support compliance activities, including audit readiness, Corrective and Preventive Actions (CAPA), and process improvement.
Act as backup for software validation or other quality activities as needed.
Ensure quality assurance programs and policies are maintained and modified regularly.
Facilitate uniform standards worldwide and enable best-practice sharing.

Benefits

Competitive salary and flexible benefits package.
Health insurance.
Dental insurance.
Vision insurance.
Health Savings Account access.
Healthcare Flexible Spending Account access.
Life insurance.
Long-term disability leave.
Dependent daycare spending account.
Incentive plans, including eligibility for a short-term incentive (STI).
401(k) plan with company match.
Short-term disability coverage.
Paid time off and holidays.
Employee Stock Purchase Plan.
Employee Assistance Program.
Eligible employees may receive access to the Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.