QMS Intern

Quality Management System (QMS)

• Maintain and improve the Quality Management System in accordance with ISO 13485 and applicable regulatory requirements.
• Develop, review, and update quality procedures, work instructions, forms, and templates.
• Ensure quality system processes are implemented and consistently followed throughout the organization.
• Support electronic Quality Management System (eQMS) administration and optimization.

Document Control

• Manage document control processes, including creation, revision, approval, release, and archiving of controlled documents.
• Monitor quality records for completeness, accuracy, and compliance.

CAPA Management

• Support root cause investigations using quality tools such as:

- 5 Whys

-Fishbone Diagrams

-Fault Tree Analysis

-Pareto Analysis

• Verify effectiveness of corrective actions and maintain CAPA records.

Nonconformance Management

• Support investigation and resolution of nonconforming materials, products, and processes.
• Analyze quality trends and recommend improvements.

Audit Management

• Participate in:

-Internal audits

-Supplier audits

-External certification audits

-Regulatory inspections

• Prepare audit reports and ensure closure of audit findings.
• Support readiness activities for notified body and regulatory authority inspections.

Risk Management

• Participate in risk assessments and risk reviews.

Training and Compliance

• Ensure employees are trained and qualified on applicable procedures.
• Monitor training effectiveness and compliance metrics.

Our Mission to is partner with the world's leading medical device companies to accelerate the development and manufacturing of innovative medical devices. We look for employees who live our values; Honesty, Excellence, Accountability, Respect & Teamwork (HEART) as a part of their daily interactions with customers, peers and their communities.