Professional, skilled and accomplished in quality operations, assurance and audits in electromechanical device manufacturing and product development. Experienced in DHR review, SPC, non-conformance disposition, product and process validation, lean and Six Sigma manufacturing, process improvement and quality audits.
Work History
Specialist Quality Assurance
5 Years 1 Month
Abbott Laboratories, Diagnostic Division | 08.2021 - Current
Implemented DHR Review, quality assurance measures, ensuring accuracy in test results and adherence to regulatory requirements.
Analyzed data trends to identify process improvements in assembly and test to drive strategic decisions in product offerings and meeting MOFR.
Performed final quality inspection on ACP production.
Provided new training programs for staff, leading to higher employee retention rates and better overall performance.
Verified staff conformance to training and led cross-functional teams to reduce Human error incidences in assembly and diagnostic tests processes and improve operational efficiency and cycle time.
Represented Quality at NCMR/PE, MRB and Gemba meetings.
Verified completeness of tests including compliance to appendix D retest procedures to deliver quality work.
Developed training materials to enhance staff competency in diagnostic Alinity I Testing and gravimmetric procedures and compliance to ISO 9001 and ISO 13485 standards.
Collaborated with Engineering, Supplier Quality, R&D and Failure Analysis teams on PE/NCMR investigations on trending issues.
Collaborated in the development, revision and improvement of the execution of M & D's for diagnostic instruments (Ai and Architect) to meet MOFR and cycle time.
Mentored test technicians on best practices in testing protocols and quality assurance processes.
Analyzed test results to identify trends, providing insights for product development teams to optimize performance.
Used equipment, tools, and standardized test procedures to repair, replace and fix any cosmetic, electrical, mechanical, software and gravimmetrical issues that are encountered on instruments under test.
Implemented process improvements that enhanced testing efficiency and reduced error rates.
Collaborated with engineering teams to troubleshoot equipment malfunctions and resolve issues effectively.
Provided SME information, analysis in MRB disposition engagements.
Write Incoming Material Inspection Plans (Collection Plans (CP) for IQA.
Revise, review and assess existing Collection Plans(CP) for conformity to current engineering drawings
Liaise, consult and work with SME's to determine engineering drawing issues, changes and reviews.
Determine the KDF's, GD & T and notes that need IQA inspection.
Determine lower level BOM elements that need inspection.
Write redlines to existing CP's for revision.
Originate Change Requests(CR's) in document control APLM Teamcenter workflow.
Write Description, Reason and Justification for Change (DRJ's) for all PDLI (Pre-Defined Low Impact) DMR changes.
Quality Specialist
1 Year 11 Months
Flex Medical | 08.2016 - 07.2018
Performed quality line clearance, opening and closing after production to ensure compliance with quality standards through detailed inspections and documentation.
Performed raw material verification before production.
Analyzed product defects and initiated corrective actions to minimize recurrence.
Inspect for conformance of FAI reports to Engineering drawings.
Coordinate in the MRB disposition of non-conforming parts and materials.
Ensure compliance with standards and regulations in the approval of change inpact assessment reports on part revisions.
Collaborated with cross-functional teams to drive continuous improvement initiatives.
Education
Master of Science - Engineering Management
The University of Texas At Arlington | Arlington, TX | 11-2027
Bachelor of Science - Biomedical Engineering Technology
DeVry University | Irving, TX | 12-2013
Skills
DHR Review
SPC
Minitab
Solidworks
Schematics
Engineering Drawings
GD & T
Oracle Agile
Track Wise
SAP Quality
Power BI
APLM
CAMSTAR
MATLAB
MRB disposition
DMAIC
Documentation management
Quality assurance
Root-cause analysis
Metrology
Certification
Certified Quality Engineer (CQE) -American Society for Quality (ASQ) Since 08/2023
Certified Lean Green Belt - Institute of Industrial and System Engineers (IISE) Since 11/2022
Specialist Quality Assurance at AstraZeneca, Charter Way Macclesfield, SK10 2NASpecialist Quality Assurance at AstraZeneca, Charter Way Macclesfield, SK10 2NA