What are the responsibilities and job description for the Quality Control Lead position at Wondfo USA?
JOB SUMMARY
This position works directly with the Senior 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
- Responsible for maintaining compliance and readiness of the QC laboratory.
- Perform inspection and testing of incoming manufacturing materials we well as in-process and finished device testing according to specifications.
- Accurately document all incoming, in-process, first-article, and final inspection activities in alignment with the company’s Quality Management System (QMS).
- Collaborate with cross-functional stakeholders to develop and implement product testing procedures and material specifications.
- Lead or support investigations of Out-of-Specification (OOS) results, identifying root causes and implementing appropriate corrective actions.
- Partner with Quality Assurance to support Non-Conformance (NC) investigations and product-related complaint evaluations.
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.- 2 years of experience in GMP environments including knowledge of change management principles and industry standard QMS applications.
Strong interpersonal teamwork and organizational as well as effective oral and written communication skills.
