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Quality Assurance Manager
hace 2 meses
This is a challenging role that requires a strong background in quality assurance and inspection. As a Quality Control Manager at Aptyx, you will be responsible for ensuring that all inspection processes meet the required standards.
Key Responsibilities:
- Supervise and direct inspection personnel to ensure that all inspection processes meet the required standards.
- Review and approve process qualification protocols and reports.
- Track and analyze key performance indicators.
- Implement quality formats and maintain quality records.
- Communicate with customers and suppliers regarding quality-related matters.
- Follow up on corrective actions and maintain calibration of instruments.
- Participate in quality audits and implement improvements.
- Develop and implement quality training programs.
Requirements:
- Bachelor's degree or engineering background.
- Minimum 3 years of experience in manufacturing processes.
- Knowledge of FDA Medical Device Regulations, cGMP, ISO 13485, COFEPRIS, UL, and ISO 9001.
- English and Spanish language proficiency.
- Strong analytical and problem-solving skills.
What We Offer:
- A dynamic and challenging work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
Language: English (en-US)