QMS Specialist, Robert Half

QMS Specialist

Robert Half

Location:

United States, Milwaukee

Category:

IT - Administration

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

This role is crucial in the integration of design and manufacturing process procedures within a Quality Management System that is compliant with ISO 13485.

Job Responsibility:

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

What we offer:

medical
vision
dental
life and disability insurance
401(k) plan

Additional Information:

Job Posted:

March 24, 2025

Employment Type:

Fulltime

Work Type:

Remote work

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