Quality Engineer Resume

TECHNICAL SKILLS

CAPA Leader
CAPA Facilitator
CAPA SME.
Validation SME
Post Marketing Surveillance SME
Process Improvement SME

PROFESSIONAL EXPERIENCE

Confidential

Quality Engineer

Responsibilities:

Lead CAPA direction, guidance, instruction and development on Root Cause investigation, and techniques for effective CAPA execution and closure.
Executed and Approved CAPA VoEs.
Managed CAPAs by ensuring the entire CAPA process was working effectively, utilizing use of problem solving techniques, consistency in execution, completeness of content, clarity of content, and compliance with FDA 21CFR§820.
Verified customer complaints investigations were adequately addressed and completed on time.
Evaluated product compliance and performance utilizing data analytics, risk assessments.
Reviewed, Identified and Remediated 483Observations for CAPAs:
Ensured problem statement identified, containment actions, investigation proper content (problem investigation, risk assessment, root cause, action plans, Device history records and etc)
Created technical evaluations for design inspection.
Investigated product failures of components for root cause and prevention action compliance.
Collaborated with development team on creation of appropriate harm/hazard analysis for issues potentially impacting users and patient outcomes.
Performed trend analysis of products and system data.
Analyzed non - conformances, assisted CAPA team to determine appropriate interment containment, problem statements, root causes and identified effective resolutions.
Provided clear validation strategies and testing guidance for the FDA observation CAPA.
Resolved discrepancies between manufacturing and quality inspection criteria
Evaluated complaint information, and maintained records.
Used and maintained database and provided analysis on customer complaints.
Determined reportability of customer complaints.
Identified and documented appropriate complaint categories to assure trend accuracy within the complaint database.
Developed and implemented a problem reporting and waiver system tailored to the needs of the project.
Provided technical expertise and assistance in handling customer customer complaints to comply with the current FDA and International reporting regulations.
Coordinated the review, approval, submission, and production of final documents, in accordance with the established timelines.
Completed investigations which include execution or coordination of product returns and subsequent evaluations
Investigated product failures of components for root cause and prevention action compliance.
Coordinated and reviewed actives with CAPA task owners to ensure adequate documentation of the CAPA activities and actions taken in a timely manner.
Generated CAPA Effectiveness monitoring plans for appropriate and effective corrective / preventive actions with CAPA owners.
Improved timeliness of root cause analysis and complaint submissions.
Analyzed Suppliers validation data, determined results, presented conclusions and recommendations in reports.
Initiated and followed-up on Supplier Corrective Actions (SCAR) to ensure complete and effective root cause analysis and corrective action implementation
Analyzed in house and supplier non-conformance's & customer complaints.
Identified the root cause and put effective procedures in place to prevent reoccurrence.
Applied new risk assessment evaluation criteria to the dFMEA.

Confidential

Quality Engineer

Responsibilities:

Knowledge of OSHA and FDA guidelines
Process Validation
Performed analyses using SAS and MATLAB programming techniques
Responsible for analysis: SPSS
Familiar with protocol development for the analytical section for phase I trials
Collaborated with cancer biology researchers and supported cross-functional teams
Implement data analysis algorithms
Analyze clinical data using statistical approaches like longitudinal analysis, mixed effect modeling, logistic regression analyses, and model building techniques
Assisted with presentations and onsite training for FDA representatives.
Generated data reports by exporting data from instruments into Microsoft Excel. Performed statistical analysis using SAS 9.4.

Confidential, Tampa

Quality Engineer

Responsibilities:

Analyzed plant based extraction effects on inhibition of cancer cell growth in numerous samples.
All research was conducted in a strict quality control/ quality assurance (QA/QC) environment with strict sample and analysis protocols to obtain the highest quality data.
Reorganizing and correcting data
Performing data clean.
Utilization of statistical analysis and mixed model on systematic review data to find preoperative risk factors for cell line mechanism changes.
Reviewing literatures to summarize expected risk factors.
Statistical Analysis
Provided correspondence and coordinated information and responses with staff; maintained office records.

We provide IT Staff Augmentation Services!

We'd love your feedback!

Resume Categories

Client Services

Job Seekers

Visa Sponsorship