Job Description

Overview:

We are seeking a dynamic and versatile Quality Engineer (QE) to join our team. This position involves overseeing a wide variety of QA responsibilities in a fast-paced, production-oriented environment. You will be responsible for handling CAPA (Corrective and Preventive Actions), deviations, validations, SCARs (Supplier Corrective Action Requests), and out-of-specification (OOS) results.

Key Responsibilities:

• Oversee CAPA, deviations, validations, SCARs, and OOS management to ensure compliance and quality standards.
• Coordinate vendor validations and ensure successful completion of PQ validations.
• Actively contribute on the production floor to monitor and enhance quality systems.
• Adapt quickly and take on new projects as they arise, shifting focus as required in a high-paced, ever-changing environment.
• Manage multiple high-priority projects simultaneously.
• Apply technical writing skills to create and maintain accurate, thorough documentation for QA processes.

Required Qualifications:

• 3-6 years of experience in quality engineering or a related field.
• Familiarity with GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) in the pharmaceutical, medical device, or cosmetic industries.
• Strong technical writing skills for documentation and reporting.
• Ability to work independently and in a collaborative team environment.

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