Senior Quality Engineer - Medical Device - Hialeah, FL

In this role you will report directly into the VP of Quality and be responsible for:

• Supporting new product development activities and maintaining compliance with design control requirements.
• Providing hands-on quality engineering support for process development, manufacturing transfers, validations, and product or process changes.
• Managing risk management activities in accordance with ISO 14971, including hazard analyses and risk assessments.
• Reviewing engineering changes and evaluating quality, validation, and risk impacts.
• Developing, executing, and reviewing process validations, test method validations, and related documentation.
• Utilizing statistical tools and software to analyze process capability, complaint trends, nonconformances, and quality metrics.
• Leading investigations into product failures, deviations, supplier issues, nonconformances, and CAPAs while driving effective corrective actions.
• Supporting complaint handling, failure analysis, post-market surveillance, and regulatory reporting activities.
• Qualifying, monitoring, auditing, and improving supplier performance while maintaining approved supplier records.
• Partnering with manufacturing, engineering, and supply chain teams to improve product quality, process capability, and operational performance.
• Reviewing supplier quality documentation, change notifications, validation records, and corrective action responses.
• Participating in internal audits, supplier audits, regulatory inspections, and audit readiness activities.
• Maintaining and improving quality procedures, work instructions, forms, specifications, and training materials.
• Supporting inspection activities and ensuring inspection methods, acceptance criteria, and sampling plans remain compliant and effective.
• Serving as a key quality resource for the VP of Quality while providing guidance and training across the organization.
• Conducting hands-on product investigations using microscopes, vision systems, and other analytical tools to determine root cause and support issue resolution.
• Collaborating remotely with manufacturing resources at a contract manufacturing site in Central America to address quality and process concerns.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.