Senior Quality Assurance Specialist
4 weeks ago
Healgen Scientific is a global leader in developing, manufacturing, and commercializing In-Vitro Diagnostic test systems. We are seeking a highly skilled Senior Quality Assurance Specialist to join our team.
Job Summary:The Senior Quality Assurance Specialist will be responsible for ensuring that our products and services meet the desired quality standards. This includes developing and implementing quality control procedures, monitoring product performance, and identifying and addressing quality issues.
Key Responsibilities:- Inspecting incoming raw materials, in-process, and finished products
- Assisting manufacturing with batch release and other relevant documentation
- Assisting with post-market monitoring of our products
- Assisting with training as required
- Maintaining equipment calibration logs and temperature and humidity monitoring in the warehouse and manufacturing area
- Maintaining proper documentation of incoming and outgoing products
- Facilitating the periodic review of documents to comply with internal QMS requirements
- Ensuring completed documentation meets internal quality standards
- Supporting the Internal Quality Audit and External Audits at the facility
- Managing relevant record logs for Quality Events; working on CAPA, SCAR, and deviation, as required
- At least 4-5 years of relevant experience and a relevant bachelor's degree OR at least 8-10 years of relevant experience without a degree, preferably in the Medical Device industry
- Ability to work with a cross-functional team on an international stage
- Ability to communicate effectively in written and spoken English
- Ability to troubleshoot as necessary
- Ability to prioritize tasks effectively
- Initiative and proactivity in day-to-day tasks
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