Quality Assurance Specialist
hace 2 días
Viant Medical is seeking a highly skilled Quality Assurance Specialist to join our team.
Job Summary:
The Quality Assurance Specialist will be responsible for providing quality engineering support to the development and production of Class I, II, and III medical devices. This includes representing quality in production process efforts, quality planning, process validations, FMEA, and risk analysis.
Main Responsibilities:
- Prepare and update quality documents required to sustain manufacturing processes.
- Review and execute documentation created by the Manufacturing Engineering department.
- Support analysis, review, and implementation of new methodologies and processes.
- Check and provide support for NCs, Complaints, Calibration, SCARs, and Environmental Monitoring.
- Maintain and follow up on CAPA and supplier files.
- Support qualifications (IQs/OQs/PQs/PPQs/TMVs) with approved protocols.
Requirements:
- Bachelor's degree in a relevant field.
- Minimum 5 years of experience in quality assurance or a related field.
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal skills.
Preferred Qualifications:
- Master's degree in a relevant field.
- Experience with ISO 13485 and FDA regulations.
- Knowledge of Six Sigma principles and tools.
What We Offer:
- Competitive salary: $110,000 - $140,000 per year.
- Benefits package including health insurance, 401(k), and paid time off.
- Opportunities for professional growth and development.
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