Senior Investigator – Quality

Reporting to the Associate Quality Director, the Senior Quality Investigator is responsible for conducting thorough investigations of customer complaints, internal non-conformances, and other quality-related issues within a Medical Device environment.

The role ensures compliance with regulatory standards and internal procedures, aiming to identify root causes and implement corrective and preventive actions (CAPA).

This Quality position collaborates directly with Manufacturing, Engineering, Supply Chain, Quality Platform, R&D, Design assurance, Technical Services, Customer and Suppliers to ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks.

Regular, punctual attendance is an essential job function.

Job Responsibilities:

• Engage with the local business and associates toward the effective promotion of organizational goals.
• Proactively identify and work through obstacles that may hinder associates from focusing on and delivering their individual impact goals.
• Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by the departmental goals.
• Development and implementation of best quality practices.
• Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards.
• Maintain positive and cooperative communication and collaboration with all levels of employees.
• Pursue and maintain a functional knowledge of global regulation affecting the local business.
• Contributes to the attainment of budget goals by managing department spends, may manage a formal budget.
• Other duties as required to support the needs of the business.
• Contributes to the attainment of budget goals
• Prepare and deliver root cause investigation and technical writing training materials and deliver training to BDM-PS personnel
• Provide regular updates to the plant leadership team regarding events, deviations and investigations
• Identify gaps in critical elements of the Quality System or production process and recommend actions