Quality Assurance Engineer

2 weeks ago

Miami, United States Suru Full time

Job Overview

The Quality Assurance Engineer at Suru will play a pivotal role in establishing, applying, and refining quality metrics to enhance operational efficiency across the organization. This position requires collaboration with various departments to ensure adherence to standards and the successful execution of compliance initiatives. The Quality Assurance Engineer will lead investigations into non-conformances and deviations, implement corrective and preventive actions, and address customer complaints.

Key Responsibilities

1. Analyze quality process controls, evaluate customer feedback, and assess returned products to propose enhancements and necessary corrective or preventive measures.

2. Initiate and oversee technical inquiries concerning internal non-conformances and customer complaints.

3. Conduct comprehensive investigations that yield clear analyses and actionable recommendations for corrective measures. Collaborate across departments, including Operations, Processing, Engineering, and Regulatory, to resolve non-conformances and complaints within established timelines.

4. Execute tasks that require independent judgment in selecting and adapting standard techniques, procedures, and criteria.

5. Collaborate in a cross-functional environment to ensure timely completion of compliance-related documentation.

6. Provide quality expertise during the rollout of process improvement initiatives.

7. Perform data analysis, which may involve basic statistical tools or calculations.

8. Maintain an understanding of all Quality Assurance Procedures and assist in the development and review of Quality Assurance Policies and Standard Operating Procedures related to quality operations.

9. Ensure compliance with all applicable federal, state, and company regulations, policies, and procedures.

Qualifications

A Bachelor's degree in Engineering or a related technical field is required (e.g., Biology, Chemistry). A minimum of 3 years of relevant experience in Engineering or Quality, with proficiency in AATB and FDA regulations, is essential. Experience in the Tissue Banking, Pharmaceutical, Medical Device, or Biologics sectors is preferred. Familiarity with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs) is necessary. Proficiency in computer applications (MS Project, word processing, spreadsheets, and presentations) is required. Strong oral and written communication skills are essential.

Work Environment

This role will be performed in an office and laboratory setting, with occasional access to clean rooms and exposure to human tissue and associated hazards.

Physical Requirements

While performing the duties of this position, the employee is frequently required to sit for extended periods. Occasionally, the employee may need to lift or move items weighing up to 20 pounds.

Direct Reports

This position does not have any direct reports.

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