Prin Quality Systems Spec - CAPA

MiniMed

$109K — $185K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Baccalaureate degree with 7 years of relevant experience, or advanced degree with 5 years
  • Expertise in quality control and CAPA processes
  • Familiarity with regulatory compliance and audit preparation
  • Strong analytical skills for process oversight and documentation
  • Ability to coordinate legal requests and handle investigations

Responsibilities

  • Oversee development and maintenance of quality programs and procedures
  • Interpret and assure compliance with internal and external regulations
  • Conduct ongoing process analysis to enforce regulatory requirements
  • Lead audit preparation and address findings with inspectors
  • Prepare reports and documentation for stakeholders
  • Coordinate legal requests for government investigations
  • Ensure ongoing modification of quality assurance programs

Benefits

  • Health, dental, and vision insurance
  • Access to Health Savings and Flexible Spending Accounts
  • Life and long-term disability insurance
  • 401(k) plan with company match
  • Employee Stock Purchase Plan
  • Paid time off and holidays
  • Employee Assistance Program
  • Non-qualified Retirement Plan Supplement and Capital Accumulation Plan
Full Job Description
We anticipate the application window for this opening will close on - 17 Jul 2026

The Principal Quality System Specialist - CAPA will assist with all aspects of the CAPA process, through investigation, helping to determine corrective and preventive actions and effectiveness checks, monitoring action implementation, and completion of effectiveness checks, while working in the electronic CAPA system. This role requires you to work 3 days on-site at our Northridge, CA

Responsibilities may include the following and other duties may be assigned
  • Provides oversight for the 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 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
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
  • Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
  • Co-ordinates legal requests in support of government investigations or litigations
  • 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


Required Knowledge and Experience:
  • Requires a Baccalaureate degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience

Nice to have:
  • Mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience
  • May have broad knowledge of project management
Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.
Salary ranges for U.S (excl. PR) locations (USD):$109,000.00 - $185,000.00

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $109,000 - $185,000 USD

This position is eligible for a short-term incentive called the Short Term Incentive (STI).

At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.

For further details about our comprehensive benefits, we encourage you to visit the link below.

MiniMed Benefits Overview

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