Quality Assurance Specialist

Key Responsibilities

• Administer and maintain an eQMS (including but not limited to Document Control, Training Management, CAPAs, NCs, and other quality records) with some guidance.
• Administer and maintain the purchasing process for purchase orders that fall under the QMS.
• Administer and maintain and track inventory and quarantined materials that are within Precision’s QMS under guidance from Quality Engineers.
• Create/manage/assist assembly build requests for all R&D and clinical product builds.
• Support quality team in executing reworks, generating labelling, and qualifying lower-risk suppliers and equipment.
• Track clinical build inventory, including material allocation, kitting, and reconciliation across R&D and clinical product builds.
• Auxiliary support for Incoming Quality Assurance (IQA) inspection activities, including receiving inspection and disposition of incoming materials and components.
• Support internal and external auditing processes through notetaking and assisting the Quality Manager and Engineers in gathering required documentation.
• Support quality system processes including CAPAs, internal audits, NCRs, Supplier Quality and Complaint Handling systems
• Perform additional responsibilities or other functions as assigned.

Skills, Knowledge and Expertise

• BS or more in a relevant scientific discipline.
• A minimum of 1-3 years’ medical device industry experience is necessary (can be internship experience).
• Excellent interpersonal written and verbal communication skills.
• Ability to focus on and achieve scheduled milestones, including contingency planning.
• Knowledge and understanding of FDA regulations (21 CFR 820), ISO 13485, and ISO standards related to medical device manufacturing.
• Experience in working with Class II or III medical devices.
• Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.