Quality Engineer/Quality Specialist
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Accentuate Staffing is working with a growing medical device company in the RTP area with potential for a lot of career growth. We are hiring for a Quality Engineer/Quality Specialist.
Responsibilities:
- Help create, monitor, and improve ISO 13485 and 21 CFR 820 quality management system (QMS)
- Develop processes and write procedures to ensure regulatory requirements and business needs are efficiently and effectively met.
- Manage or assist in the management of the following systems:
- Corrective Action and Non-Conforming Materials
- Training
- Equipment validation, maintenance, and calibration
- Complaints and Post-market Feedback
- Internal and Supplier Audits
Requirements:
- 4-year technical degree
- 1-7 years’ experience in the medical device industry
- Knowledge of ISO 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
