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Quality Control Lead
4 months ago
**JOB SUMMARY**
This position works directly with the Quality Systems Manager and Quality Assurance Associates toward the implementation of a Quality Management System in compliance with ISO 13485.
The Quality Control Lead is a part of the Quality team and works with manufacturing and engineering departments and is responsible for quality procedures within the manufacturing.
**RESPONSIBILITIES**
- Perform inspection and testing of incoming manufacturing materials we well as in-process and finished device testing according to specifications.
- Document incoming, in-process, production first article inspection and outgoing quality inspections following the company’s quality management system guidelines.
- Works with different stakeholders to develop and implement product-related procedures and specifications.
- Leads development of environmental monitoring including air and water quality.
- Leads development of cleaning procedures and cleaning validation and verification in manufacturing areas.
- Leads or supports investigation of Out of Specification events.
- Works with Quality Assurance in the investigation of Non-Conformances as appropriate.
**QUALIFICATIONS**
- Bachelor’s degree in chemistry, biology, or science-related field.
- 2+ years of Quality Control experience in the Biotech industry. Experience in lateral flow in-vitro device is preferred.
- Strong interpersonal teamwork and organizational as well as effective oral and written communication skills.
