Job Title: Quality Assurance Director
Description:
* Lead critical projects for new product introduction, managing validation studies and collaborating with various internal and external stakeholders to ensure timely completion.
* Ensure the company's quality management system aligns with international standards such as ISO 9000 and ISO 13485, implementing process improvements to enhance efficiency.
* Manage a team of quality engineers and oversee systems related to production support, customer interaction, and Corrective and Preventive Actions (CAPAs).
* E nsure Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities.
Responsibilities:
* Leadership Role: Be a key member of the Quality Leadership Team, leading the Quality Engineering Team through daily management, performance reviews, and delegation to drive results-oriented teams.
* Continuous Improvement: Support programs like Six Sigma to enhance processes and product quality by identifying areas for improvement and implementing corrective actions.
* CAPA Management: Ensure Corrective and Preventive Actions (CAPAs) are completed in compliance with regulatory standards, following established procedures to minimize downtime.
* GMP Oversight: Ensure Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities, maintaining documentation to meet regulatory requirements.
* Documentation: Prepare and maintain documentation to meet regulatory requirements, ensuring accuracy and completeness in records.
Qualifications:
* Industry Experience: At least 5 years in an ISO environment, preferably in the medical devices or pharmaceutical industry, with experience in process validation, sterilization, and cleanroom environments.
* Supervisory Experience: A minimum of 3 years in a supervisory role, indicating the need for leadership skills and ability to manage teams effectively.
* Technical Knowledge: Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous.
* Advanced Technical Writing Skills: Required.
* Regulatory Knowledge: Experience with FDA requirements and audit.
* Process Expertise: Experience in process validation, sterilization, and cleanroom environments is highly desirable.
Key Skills:
* ISO 9000/ISO 13485
* Six Sigma
* Statistical Process Control (SPC)
* Good Manufacturing Practice (GMP)
* Technical Writing
* FDA Requirements
Benefits
This role offers opportunities for career advancement, professional growth, and development in a dynamic and challenging environment.
The selected candidate will be part of a talented team that strives for excellence in delivering high-quality products and services.