VANESSA RODRIGUEZ
Tijuana
Summary
Forward-thinking and results-driven professional with progressive experience in implementing quality management across manufacturing organizations. Demonstrates expertise in leading supplier quality management implementation and supporting quality management system audits, utilizing in-depth knowledge of standards and best practices in the medical industry to ensure compliance in regulations. Collaborates effectively with cross-functional professionals, vendors and clients to ensure efficient manufacturing operations.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Quality Control Engineer
BD
07.2022 - Current
- Contributed to process qualifications for new products introduction.
- Lead non-conforming material handling through quality notifications for identification, segregation and material disposition.
- Improved customer satisfaction levels by effective corrective actions and solutions implementation.
- Supported on corporate and external audits ensuring ISO 13485 and 9001 compliance; besides, implementing corrective and preventive (CAPA) actions.
- Performed risk assessment forms including CAPA requests and product in the field (ship holds).
- Monitored compliance on quality metrics (non-conformances, deviations, customer complaints, reworks, audit findings), analyzing data to proposed action plans in order to reduce variability and increment first pass yield on the line.
- Developed inspection plan based on design specifications, ensuring all critical dimensions and performance criteria are verified throughout the receiving and manufacturing process.
- Drive root cause analysis and investigations to determine 80-20 for failures and defects.
- Presented monthly data in operations quality review, capa review board and management review meetings to Functional Management.
- Risk management implementation (pFMEA and control plans) for each product family on the business unit.
Quality Assurance Engineer
NEOTech
06.2020 - 07.2022
- Brought into manage the implementation of quality standards in assembly line process for manufacturing electronic Printed Circuit Boards (PCBAs), ensuring quality of finished products and monitoring quality control processes to reduce rate of defects.
- Improved quality of manufactured products in the assembly line process by implementing quality controls as fixtures and poka-yokes and maximize outputs of the line.
- Ensure customer satisfaction by leading weekly customer audits.
- Addressed customer complaints investigations and navigate solutions effectively by liaised with the crossfunctional team.
- Managed training on CFR Title 21 part 820, 210 and 211, ISO 13485, MDSAP and internal standards for inspectors to prepare them for a quality management system audit
- Monitored and trend site key process indicators (KPI) in target to presented data in the management review and quality performance meetings.
- Conduct QMS and internal audits based on ISO 13485 along the site, as well as support in the war room during external audits.
Supplier Quality Engineer
Medtronic
07.2017 - 05.2019
- Managed a scorecard for a catalogue of 300+ suppliers across different segmentations, developing relationships with them to facilitate effective review of supplier performance and negotiated with them a quality/non-disclosure agreement and purchasing controls.
- Selection, evaluation and qualification of new supplier or component; evaluation of product quality impact.
- Governed global approved supplier list; monitored supplier control through a monthly scorecard, supplier measurement and feedback.
- Collaborated with quality manager to improving process control, risk management and supplier control, measurement and feedback.
- Perform an on-site supplier audit and supplier segmentation.
- Performed supplier qualification according 21 CFR Part 820, 210 & 211 QMS Regulation.
- Provided support on internal and external audits addressing quality management system to ensure compliance with FDA, MDSAP, CFR Title 21 and ISO 13485; as well as surveillance and on-site supplier audits support to the leader auditor.
- Opened corrective action to suppliers to identify quality key issues such as material rate of rejects, adverse events as recalls, and monitored supplier corrective actions dealing with suppliers upon observation of poor-quality performance.
- Managed supplier documentation organizing records and supplier certifications and reviewing completed audit reports as well as ISO standard documentation and supplier quality agreements.
- Lead the supplier approval process by assessing, manufacturing, quality management system capabilities.
- Worked with sourcing to find solutions and identify potential suppliers.
Quality Assurance Intern
Integer Holdings (formerly Greatbatch Medical)
08.2015 - 06.2017
Education
Bilingual Education
Lexis English
Brisbane, AU11-2019
Bachelor of Engineering - Industrial Engineering
Universidad Autónoma de Baja California
01.2015
Skills
- Team player
- Leadership
- Analytical Problem-Solver
- Cross-Functional Teamwork
- Commitment to Continuous Improvement
- Motivated Self-Driver
- Risk Evaluation
Languages
English
Spanish
Professional Development
- Certified Quality Engineer, Lean Sigma, Mexico, 2018
- MDSAP Training, Medtronic, Mexico, 2017
- Internal Auditor (ISO 13485:2016), Medtronic, Mexico, 2017
Certification
- Certified Quality Auditor (CQA) - American Society for Quality (ASQ).
Timeline
Quality Control Engineer
BD
07.2022 - Current
Quality Assurance Engineer
NEOTech
06.2020 - 07.2022
Supplier Quality Engineer
Medtronic
07.2017 - 05.2019
Quality Assurance Intern
Integer Holdings (formerly Greatbatch Medical)
08.2015 - 06.2017
Bachelor of Engineering - Industrial Engineering
Universidad Autónoma de Baja California
- Certified Quality Auditor (CQA) - American Society for Quality (ASQ).
Bilingual Education
Lexis English
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