Senior QA Leader - Medical Devices & Compliance

Intepros; Kinston (NC); Vor Ort; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

IntePros in Kinston, NC is seeking a Sr. Quality Assurance Associate to oversee quality programs in a medical device manufacturing context.

The role focuses on improving processes, archiving audits, and collaborating with cross-functional teams to resolve quality issues. Candidates should have at least 5 years in regulated QA, knowledge of ISO 9001/13485 and FDA 21 CFR 820, and experience with audits (MasterControl, SAP, SharePoint).

Qualifikationen

• Minimum 5 years experience in regulated Quality Assurance / Document/Configuration Control.
• Experience with Medical Device Product Development Lifecycle Activities, Verification / Validation Activities, Risk Management, DHF Activities preferred.
• Experience with quality systems such as ISO 9001, ISO 15378 and ISO 13485, 21 CFR 820 preferred.
• Experience Leading Internal / External Audits, MasterControl, SAP and Share Point preferred.
• Experience with customer interface and meeting customer expectations preferred.

Aufgaben

• Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes.
• Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed.
• Independently performs supplier audits and corporate facility audits.
• Manage multiple project tasks and effectively coordinate handling of customer feedback and complaints.
• Lead assessment and closure of customer complaints, ensuring adherence to established procedures and documentation.
• Lead the evaluation and resolution of customer complaints, ensuring adherence to prescribed procedures and comprehensive documentation.
• Coordinate communication between internal teams and customers
• Regularly analyze data trends, drive improvements and meet customer expectations through efficient reporting and communication
• Reviews, revises, and creates operating procedures to ensure compliance with all related external requirements, internal procedures or instructions, and the West Quality Manual.
• Ability to lead meetings with customers, employees and contractors as necessary to manage changes.
• Establishes monthly KPI’s and metrics to Quality Leadership.
• Drive continuous quality improvement projects across the enterprise for increased compliance and to create efficient use of company resources.

Kenntnisse

QA

Audits

Analytics

Communication

CAPA

Problem solving

MS Office

Ausbildung

Bachelor's Degree In Engineering or Science

Master's Degree In Engineering or Science preferred

Tools

MasterControl

SAP

SharePoint

Jobbeschreibung

IntePros in Kinston, NC is seeking a Sr. Quality Assurance Associate to oversee quality programs in a medical device manufacturing context.

The role focuses on improving processes, archiving audits, and collaborating with cross-functional teams to resolve quality issues. Candidates should have at least 5 years in regulated QA, knowledge of ISO 9001/13485 and FDA 21 CFR 820, and experience with audits (MasterControl, SAP, SharePoint).