Medical Device Quality Systems Engineer
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Accentuate Staffing is looking for a Quality Systems Engineer at an innovative Medical Device Company in the Raleigh, NC Area.
The candidate will help create, monitor, and improve ISO 13485 and 21 CFR 820 quality system procedures to ensure compliance requirements are met efficiently and effectively and in support of company objectives. In addition, as a quality team member, the candidate will provide QMS support for all departments taking on roles in several areas to support monitoring and advancing the system’s needs.
Responsibilities:
- Works with all internal stakeholders to identify and implement improvements to the QMS
- Identifies and facilitates corrective and preventative actions
- Maintains document and record management system ensuring compliance with 21 CFR Part 11
- Maintains electronic employee training program
- Maintains equipment maintenance and validation program for test and manufacturing equipment
- Ensures that nonconforming materials are identified and dispositioned
- Reviews documents and records to ensure they comply with internal requirements
- Reviews complaints and feedback and facilitates investigations and performs investigations, as required.
- Assists in internal and external audits
- Assists in qualifying suppliers and maintaining an approved supplier list
Requirements:
- 4-year technical degree in engineering or another technical field
- 1-5 years experience in the medical device industry
- Knowledge of 13485 and 21 CFR 820
- Experience with Product Lifecycle Management (PLM) or electronic Quality Management System (eQMS) preferred (Agile, Arena, MasterControl, Propel, etc.)
- Experience writing SOPs and work instructions
- Proficiency in Microsoft Office
- ASQ certification a plus
