Quality Assurance Manager

QA Manager

About The company

Hairstetics is focusing on bringing a unique solution to women's androgenetic alopecia and later to all Alopecia affected populations. To the doctors Hairstetics is offering a user-friendly device easily operated by a physician in a fraction of the time compared to existing solution of natural hair transplantation.

Hairstetics already obtained the following Certificates for its products: a CE certificate, ANVISA certificate in Brazil, a Free Sale Certificate (FSC) and home country registration from AMAR (Israel). The company is also ISO 13485 certified.

Responsibilities:

• Deep dive into feature requirements and designs, implement efficient quality methodologies to ensure QA standards.
• Support QA activities related to product development, manufacturing transfers, and ongoing operational processes.
• Manage and control Quality Management System (QMS) processes, including deviations, CAPA, complaints, changes, and training.
• Maintain a comprehensive understanding of quality and regulatory requirements, with a focus on ISO 13485 compliance. And CE standards.
• Demonstrate meticulous attention to detail in all QA-related tasks.
• Work effectively under pressure to meet quality and project deadlines.

Requirements:

·      Experience of at least 4 years in QA position(s) within the medical device industry.

·      BA degree or higher in relevant science or engineering subject.

·      Proficiency in managing and controlling QMS processes, including deviations, CAPA, complaints, changes, and training.

·      Thorough understanding of GMP requirements.

·      Familiarity with technical drawings and specifications.

·      High-level proficiency in English, both written and spoken.

·      Excellent writing skills in English and Hebrew, including the ability to create specifications for quality control,

MRB, SOPs, and quality records.

·      Experience in design control and Design History File (DHF) is an advantage.

·       Collect and report data related to products and processes quality.

·      · Responsibility of approving DHR file for each production lot.

·      · Release of final products.

·      Report to the CEO on the efficiency and performance of the quality system.

C.V to: [email protected]