QMS Project Manager

Align Technology•Morrisville, PA

56d

About The Position

This position is ideal for experienced professionals with strong QMS and Project Management expertise to join the Invisalign Multi-Site QMS team as a QMS Project Manager. You will support the harmonization of quality processes across sites, identify and implement opportunities for continuous improvement, and enable data-driven decision-making. The position will collaborate with multiple stakeholders across the organization, including operations quality leaders, regulatory affairs, operations, and product development to achieve organizational goals and foster a culture of quality.

Requirements

strong QMS and Project Management expertise

Responsibilities

Lead QMS continuous improvement projects to increase efficiency of the QMS and drive organization compliance
Facilitate cross-functional improvement projects that enhance QMS processes, reduce waste, and promote best practices.
Lead the development, implementation, and continuous improvement of the QMS to ensure compliance with applicable regulatory requirements and relevant international standards (e.g., ISO 13485, MDSAP, EU MDR, FDA QSR/QMSR, etc.).
Monitor, analyze, and report on QMS effectiveness and compliance metrics through management review.
Manage Internal Audit Program and ensure there is adequate resourcing to conduct audits.
Ensure the QMS and business are in a state of audit readiness.
Serve as a point of contact for external audits and regulatory inspections; support responses to audit observations and ensure effective corrective actions.
Champion digital transformation initiatives (as applicable) to enhance quality process efficiencies.
Provide guidance on Standard Operating Procedures (SOPs), work instructions and other QMS documents.
Provide training and mentorship for quality processes.
Promote a strong quality culture across the organization.
Stay abreast with evolving regulatory requirements, standards, and best practices.
Interpret and communicate regulatory changes to internal stakeholders and ensure timely updates to quality processes and documentation.