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Assoc Analyst, Quality Systems

3 months ago

San Diego, United States INTELLECTT INC Full time

Role:

Assoc Analyst, Quality Systems

Location:

Hybrid Southern California

Duration:

6 Months

Job Description

The main function of a quality systems analyst is to support the spinoff of Critical Care’s Business Unit from Edwards. The analyst will work with business representatives to understand and document the business requirements, processes and workflows and update procedures to stand alone for the Critical Care Quality Management System. Partner effectively with all levels of the organization to redline procedures, implement feedback and proactively identify and resolve problems and escalate as required. Collaborate with Subject Matter Experts for the proposed solutions. Work with the Quality management team to ensure solutions are successfully developed and deployed.

Key Responsibilities

Update Quality Management System procedures based on feedback from business representatives. Drive to resolve any issues that arise with swift action. Drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation

Additional Skills:

Experience in a quality and/or manufacturing environment in the medical device industry preferred Proven expertise in MS Office Suite Good project management skills and related software tools preferred Good communication and interpersonal relationship skills Excellent written and verbal communication skills including negotiating and relationship management skills Strong problem-solving and critical thinking skills

Technical Writing Skills

Experience with document control and ISO 13485 is a plus

Education and Experience:

Bachelor's Degree or equivalent in in related field of study Experience in a quality and/or manufacturing environment in the medical device industry required 0-2 years of experience required

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