Description
About the JobKEY RESPONSIBILITIES
Assist and support ACD with initial set-up, training and compliance of the Quality Systems, monitoring of conformance to QA processes & standard for manufacturing. Performs evaluation of internal controls, communications, document control & risk assessment as related to compliance with internal & external quality & regulatory standards such as ISO 13485 & FDA QSR, CE Mark/IVDD.
May be responsible for implementation of the following quality system elements: CAPA, NCP, PCO, QA product review & release, audits, quality metrics, management review, recalls, customer complaints, risk management, supplier control and customer related processes.
Work closely with QA Manager, R&D, Production, Operations, Technical Services and Commercial teams to identify and support the Quality System compliance and customer needs. You will take initiative and be willing to learn new technologies quickly and adapt to shifting priorities.
QUALIFICATIONS
* 3 to 5 years experience in In Vitro Diagnostics (IVD) industry in Quality Assurance.
* Proven skills in IVD Medical Devices, Quality Management Systems (ISO 13485, QSR, CMDR, worldwide IVD QA systems) development, implementation, compliance, as well as audits, ISO certification, IVDD/CE mark, FDA IVD, ASR, GPR, RUO, IUO, LDT compliance.
* Fluent in In Vitro Diagnostics (IVD) CAPA, NCP, PCO, document control, audits, quality metrics, customer complaints, post-market surveillance/recalls, management review, design control and risk management.
* Prior experience in process validation, QC, assay development/validation, supplier management, and customer related processes are a plus.
* Excellent computer skills, including working knowledge of common QA Document Control and QMS, ERP and CPM software and databases.
* Excellent people, verbal and written communication skills.
* Ability to thrive and flourish in a fast-paced growing start-up environment
To find out more about Real please visit www.realstaffing.com