Senior Quality Systems Specialist
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 the communication skills to work effectively across the organization. The role partners with stakeholders in Manufacturing, CAPA, Supplier Quality, Audit, and Regulatory Affairs to align quality systems with requirements and regulatory expectations. The specialist reviews and drives quality management system (QMS) changes supporting product and process releases and updates, and contributes to process improvements and quality metric reviews. The role also provides guidance on regulatory and internal requirements, supports audits and inspections, prepares reports and documentation, and leads or supports compliance activities, including audit readiness and Corrective and Preventive Actions (CAPA). The specialist may provide backup support for software validation or other quality activities and helps maintain consistent quality standards and practices across the organization.
Requirements
- Bachelor’s 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, especially Word, Excel, and PowerPoint.
- Strong knowledge of quality regulations and standards.
- Ability to manage competing priorities.
- Strong verbal and written communication skills.
Nice To Haves
- Mastery of a specialty area and knowledge of industry practices, typically gained through advanced education and experience.
- Medical device industry experience and relevant regulatory and standards knowledge.
- Direct experience in audit backroom or front room roles.
- Experience with non-product computer system validation, regulations and standards assessment, translation coordination, or multi-site/QMS entity coordination.
- Broad knowledge of project management or process improvement methodologies.
- Six Sigma, Kaizen, PMP, or other project management certification.
- Experience with Agile, Trackwise, Microsoft Teams, Project, or Power BI.
Responsibilities
- Review and drive QMS changes supporting product and process releases and updates at local and enterprise levels.
- Communicate and collaborate with cross-functional stakeholders and build positive working relationships across the organization.
- Coordinate with team members, the manager, and other stakeholders to support day-to-day activities and long-term goals.
- Identify, collaborate on, create, and complete QMS process improvements.
- Support monthly, quarterly, and other quality metric reviews, including facilitating, communicating, reviewing, and recording results.
- Use critical thinking and data analysis to identify outliers or concerns and take action to resolve them.
- Review and facilitate the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and internal and external standards.
- Provide coworkers with expertise and guidance on interpreting policies, regulatory and governmental requirements, and internal regulations.
- Work with operating entities to oversee continuing process analyses, enforce requirements, and meet regulations.
- Support audit and inspection preparation and resolution of findings throughout all stages of audits and inspections.
- Prepare reports and other required documentation for internal and external stakeholders.
- Lead or support compliance activities, including audit readiness, CAPA, and process improvement.
- Provide backup support for software validation or other quality activities as needed.
- Maintain and regularly modify quality assurance programs and policies.
- Facilitate consistent standards worldwide and share best practices across the organization.
Benefits
- Competitive salary and flexible benefits package.
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account access.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Incentive plans, including 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 have access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
