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Quality Engineer

3 months ago

Miami, United States Suru Full time

Job purpose


The Quality Engineer will be responsible for developing, applying, revising and maintaining quality metrics to support areas of operations at the company. The Quality Engineer must work with all departments to ensure compliance and successful and timely completion of compliance projects. The Quality Engineer will be responsible for initiating and leading non-conformances/deviations investigations, corrective and preventive action implementation, complaint investigations.


Duties and responsibilities


1. Responsible for trending Quality process controls, analyze reports and evaluate customer complaints and returned products to recommend process improvements and corrective and/or preventive actions.


2. Responsible for initiating and leading technical investigations related to internal non-conformances/deviations and customer complaints.


3. Conduct thorough investigations which provide clear and concise analysis and recommendations for corrective actions. Work cross-functionally with the Operations, Processing, Engineering and Regulatory groups, to successfully bring closure to non-conformances/deviations and complaints within defined deadlines.


4. Plan and conduct work requiring judgement in the independent evaluation, selection and substantial adaptation and modification of standard techniques, procedures, and criteria.


5. Work in cross functional department environment for timely completion of compliance associated documents.


6. Provide quality guidance during the implementation of process improvement procedures.


7. Perform data analysis that may include basic use of statistical tools or basic calculations.


8. Maintain Knowledge of all Quality Assurance Procedures and assist in the review and development of Quality Assurance Policies, Standard Operating Procedures with regards to Quality operations.


9. Ensure personal and company compliance with all federal, state, company and regulatory bodies’ regulations, policies and procedures.


Qualifications


A minimum of a Bachelor’s degree in Engineering or a related technical discipline is required (e.g. Biology, Chemistry, etc.). A minimum of 3 years of related Engineering or Quality experience, AATB, and FDA regulatory proficiency is required. Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry. Experience with Non-Conformance, Deviation, Complaint and Corrective and Preventive Actions (CAPAs). Must demonstrate advanced knowledge of computer programs (MS Project, word processing, spreadsheets, and presentations). Effective oral, written, communication and presentation skills.


Working conditions


Office Environment, Laboratory Environment, Occasional Clean Room Access, Subjected to human tissue and associated hazards and biohazards.


Physical requirements


While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.


Direct reports


No direct reports.