Quality Assurance Manager

חזרה למשרות

Biogal Labs LinkedIn

14/01/2025
יקנעם עילית

Quality Manager – Veterinary Diagnostics Manufacturing Facility

We are seeking a highly experienced and dynamic Quality Manager to spearhead the quality operations at our veterinary diagnostics manufacturing facility. This pivotal role requires ensuring adherence to the highest international quality standards, driving continuous improvement initiatives, and managing the Quality Control team. The position involves close collaboration with internal departments and external stakeholders while ensuring compliance with the stringent regulatory requirements of the medical device industry.

Key Responsibilities:

Quality Management System (QMS) Oversight:

Develop, implement, and oversee robust Quality Management Systems (QMS) in compliance with ISO 9001 and ISO 13485 standards.
Author, revise, and maintain policies, procedures, work instructions, and quality processes.
Conduct comprehensive internal audits and prepare for external audits by clients and regulatory bodies (FDA, GMP, ISO).
Lead training programs on quality management and product safety for employees.
Oversee the implementation of annual plans, including maintenance schedules, training, audits, calibrations, and validation processes.

Leadership of Quality Control and Regulatory Teams:

Manage and mentor the Quality Control team, fostering professional growth and development.
Define performance metrics and establish work plans for the team.
Troubleshoot issues, resolve challenges, and lead initiatives to enhance production quality.

Non-Conformance and Corrective Action Management:

Identify, investigate, and resolve quality deviations, including the development of comprehensive CAPA reports.
Conduct data analysis and employ statistical tools to prevent recurrence of quality issues.

Continuous Improvement Initiatives:

Lead strategic projects aimed at enhancing quality and production processes.
Integrate advanced tools and innovative technologies to elevate quality management practices.

Cross-Functional Collaboration:

Work in synergy with development and production teams to ensure seamless integration of quality standards.
Provide support in product development and ensure smooth transitions from R&D to production.

Regulatory Compliance and Strategic Readiness:

Ensure compliance with local and international regulatory standards and guidelines.
Adopt a proactive approach to regulatory changes, preparing the organization to meet evolving requirements.

Qualifications:

A minimum of 5 years of proven experience in quality management within the medical device manufacturing or biotechnology industries.
A relevant academic degree (Engineering, Biotechnology, Life Sciences, or a closely related discipline).
Certification as a Quality Management professional in applicable standards.
Comprehensive knowledge of ISO 9001, ISO 13485, and GMP requirements.
Demonstrated expertise in team leadership and project management.
Ability to excel in a fast-paced, multi-tasking environment under tight deadlines.
Exceptional proficiency in English (written, verbal, and reading comprehension).

Core Competencies:

Strong leadership and strategic management capabilities.
Outstanding interpersonal and communication skills.
Superior problem-solving and decision-making abilities.
A forward-thinking, proactive mindset with a commitment to continuous improvement.