Description

We are offering a long-term employment opportunity for a QMS Specialist. This role is crucial in the integration of design and manufacturing process procedures within a Quality Management System that is compliant with ISO 13485. This will be a remote role.

Responsibilities:

• Collaborating with the leadership team to define and scope Quality Management System integration objectives.

• Reviewing targeted Quality Management System procedures and proposing necessary adjustments to facilitate seamless process integration.

• Engaging with stakeholders for reviews and approvals, and providing them with regular updates on the status of integration.

• Participating in comprehensive reviews of selected procedures with Subject Matter Experts.

• Adapting training materials for the target Quality Management System to accommodate changes.

• Applying a systems engineering approach to ensure compliance with ISO 14971.

• Identifying stakeholder needs and translating these into Design Inputs, while also ensuring these are traceable to the Design Outputs.

• Owning the Quality Management System process, which includes maintaining accurate records and resolving inquiries.

• Using leadership skills to guide the team towards achieving compliance goals.

Requirements

• Proficiency in Marketing

• Familiarity with Procedures and Compliance

• Knowledge of Quality Review processes

• Experience in Design and Leadership Skills

• Ability to engage with Stakeholders effectively

• Understanding of Compliance Functions

• Expertise in Management System

• Proficiency in using Templates

• Ability to develop Training Materials

• Experience in End-To-End process management

• Skills in Translation and adaptation

• Must be eligible to work in the U.S.

• Knowledge of Manufacturing Process

• Expertise in System Engineering

• Understanding of ISO 13485 and ISO 14971 standards

• Experience in Process integration

• Knowledge of Very-large-scale integration

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