QA Operations Engineer

Hallura, a startup specializing in medical devices, implantable Hyaluronic acid hydrogels, located in Yokne’am, is currently seeking a QA Operations Engineer
In this role, as a QA Operation, your primary responsibility will revolve around ensuring the company operates in the highest Quality standards, in compliance with ISO 13485 and FDA 21 CFR part 820. Working directly under the supervision of the Head of QA/RA, you will assume a pivotal position in supporting the expansion of the company activities according to stringent regulatory requirements.
דרישות התפקיד
The QA Operations shall have the following responsibilities:
• Supports manufacturing and operation by establishing and maintaining testing and inspection processes.
• Responsible for calibration and maintenance activities.
• Identifies improvements and inputs into the quality planning process.
• Reviews, revises and approves action for consistency and compliance with good documentation practices, QMS and regulatory requirements.
• Supports Document Control process and engineering changes
• Manage the core QMS processes such as: non-conformities (NCs), Failures analysis, Corrective and Preventive Action (CAPA) and SCAR processes.
• Responsible for Suppliers’ quality issues.
• Participates in continuous quality improvement efforts through the evaluation of trends in key performance indicators, audits, and corrective/preventative actions.
• Support the operation and production (clean room, warehouse, supply chain, maintenance, engineering) department activities with all quality controls and demands,
• Support with Complaint investigation
• Analyze and present to management trends and statistics related to QA oversight in operations. Quality documentation review for ECOs, design control, QMS etc.
• Perform batch release as needed.

Requirements:
• Bachelor’s degree in engineering or closely related field,
• 2-4 years’ experience in a manufacturing environment and Supplier Quality in the medical device industry, including in-depth knowledge of ISO13485.
• Knowledge in Quality Control- advantage
• Knowledge in HPLC and analytical method – advantage
• Strong knowledge of the FDA and EU medical device regulations, standards and guidance documents.
• Proven experience in establishing procedures for maintaining high standards of product quality and reliability.
• Decisions made with an in-depth understanding and interpretation of procedures, policies and business practices to achieve results.
• Strong knowledge and previous work in clean room advantage

Language skills: English- writing and verbal skills
Personality: Excellent communication and leadership skills, organized, motivated