Quality Assurance Specialist
1 week ago
Earn a competitive salary of $85,000 - $110,000 per year.
About the RoleThis is an exciting opportunity to join ELITechGroup Inc. as a Quality Assurance Specialist. In this role, you will be responsible for ensuring the highest quality standards are met in our manufacturing process.
Main Responsibilities:- Quality Planning and Control: Develop and implement quality plans to ensure products meet specifications and regulatory requirements.
- CAPAs (Corrective and Preventive Actions): Investigate and resolve quality-related issues using Lean and Six Sigma methodologies.
- Nonconforming Products: Identify, track, and control nonconforming products, determining their root cause and implementing corrective actions.
- Complaint Handling: Investigate complaints, determine necessary actions, and conduct trend analysis to identify areas for improvement.
- Internal Audits / External Audits: Conduct internal audits, prepare audit reports, and participate in external audits as assigned.
- Quality Training: Provide quality training to employees, serving as a role model for adherence to processes and procedures.
- Process Control and Quality Improvement: Review and improve quality and operational processes, reducing variation and improving overall quality.
- Education: Bachelor's degree in Life Science or Engineering discipline, with three years of quality-related experience or five years of direct Quality or Regulatory experience.
- Skills: Advanced personal computer productivity programs, eQMS software, ISO13485 quality system, and FDA 21 CFR 820 quality.
- Personal Qualities: Good communication skills, confidentiality, and ability to interface with various levels of the organization and external stakeholders.
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