Quality Assurance Specialist

Support manufacturing of orthopedic medical device products pertaining to the sterilization and cleanliness of the devices. Assess the impact of manufacturing related changes on the sterilization and cleanliness attributes of finished medical device products. Familiar with cGMP / cGDP, standard laboratory techniques (i.e. USP and ISO based testing methods) and safety procedures (i.e. OSHA). Knowledgeable in scientific concepts, measures, and terminology. Able to understand and apply specific laboratory protocols. Performs QA / QC duties as required.

Responsibilities :

• Author and execute protocols and final reports to assess impact of manufacturing related changes against cleanliness requirements for impacted medical devices. May provide analysis and evaluation of materials and products at all stages of development process.
• Help manage the execution microbiological and chemistry testing both internally and externally.
• Communicate and collaborate with project owners to obtain all necessary information for assessment. May entail communication with internal operations and / or external suppliers.
• Conducts work in compliance with cGMP / cGDP, safety and regulatory requirements.