Job Title: Quality Assurance Specialist
Description:
The role of a Quality Engineer is critical in ensuring that products manufactured at the site comply with approved specifications and adhere to current good manufacturing practice and regulatory agency requirements.
Key Responsibilities:
* Ensure compliance with quality systems, guidelines, and regulations.
* Audit the quality system and verify its effectiveness.
* Investigate customer complaints, identify root causes, and implement corrective actions.
* Manage CAPA (Corrective Action Preventive Action) processes to ensure timely and effective implementation.
* Measure performance metrics and provide insights for management reviews and reports.
* Provide training to plant personnel on quality requirements and best practices.
* Verify effectiveness of corrective/preventive actions and ensure compliance with relevant regulations.
* Assist in validation activities and ensure quality system documentation is thorough and compliant.
* Review lot records, inspect incoming products, and manage supplier quality relationships.
Required Skills and Qualifications:
* Degree in Engineering, Science, Quality, or related field.
* Green Belt certification or demonstrated knowledge of statistics in an industrial environment.
* Minimum 4-6 years' experience in quality system operations in a highly regulated environment.
* Familiarity with quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820).
Benefits and Career Opportunities:
This is an excellent opportunity for a Quality Engineer to join our organization and contribute to the success of our team. We offer a competitive compensation package, opportunities for professional growth, and a collaborative work environment.
We are committed to providing our employees with the resources and support needed to excel in their roles. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.