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Quality Assurance Specialist

Company: Brightwing
Location: Auburn Hills
Posted on: January 16, 2022

Job Description:

Quality Assurance Specialist

- Skills/capabilities:
o In-depth understanding of ISO 13485:2016 and FDA 21CFR820(preferred but not a hard stop) . They are working towards the FDA 21CFR820 so previous quality standards implementation experience is helpful.
- Experience working in facilities that are compliant to aforementioned standards/requirements
o Proficient in Root Cause Analysis
o Knowledgeable with CAPA's
o Proficient in Microsoft Office
o Sharp attention to detail
o Great team player - established communication skills to ensure all stakeholders are aware
o Self-driven and able to work with minimal supervision
o Able to sit, stand and walk around for long hours at a time
o Experience and certification for Internal Audits (previous certification does not have to be current)
o Create reports documenting errors and issues for fixing
o Help to review and develop quality assurance standards and company processes/records
o Manage equipment calibration for manufacturing plant
o Lead and participate internal quality audits on a quarterly basis
- Identify processes, situations, etc., where organization is meeting requirements, as well as identify opportunities for improvement.
- Develop audit plans and schedules
- Evaluate production processes for compliance with quality requirements
- Assist with 3rd party audits

Keywords: Brightwing, Detroit , Quality Assurance Specialist, Other , Auburn Hills, Michigan

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