Turian Rosales
San Ysidro
Summary
Quick-thinking Leader recognized for success in guiding teams (30 people) to boosting performance. Practical problem-solver with excellent issue and conflict resolution skills to drive team and organizational success. Highly effective and knowledgeable in Lean Six Sigma, end-to-end quality, and risk management.
Overview
12
12
years of professional experience
3
3
Languages
Work History
Supplier Quality Engineering Leader
Johnson & Johnson
8 2023
- Leveraged developmental approach to manage Supplier Quality team, collaboratively identifying, and implementing training and growth opportunities to help further their career
- Directed contract manufacturing and 3PL operations across the globe to ensure regulatory compliance with Quality Systems Requirements, Medical Device Industry, Quality Standards, FDA & EU MDR regulations, and other applicable regulatory agencies, while striving for continuous improvement
- Oversaw Supplier performance monitoring program and Key Process Indicators to identify suppliers requiring development and improvement to ensure First Time Quality and compliance with Quality Agreement requirements
- Partnered with procurement and other cross functional teams on supplier selection and qualification process
- Analyzed quality metrics to identify major site quality risks, leveraging metrics to design strategies for supplier quality engineering department
- Provided guidance and leadership for component and finished good validation and qualification activities to assure successful adoption of sites changes, including material, process and inspection changes (PPAP, IQ, OQ, PQ, TMV)
- Developed and retained diverse and highly qualified staff; provided ongoing mentoring and performance feedback
- Set goals which aligned to department plans and directed goals and objectives execution through coaching and mentoring
- Represented Purchasing Controls during internal and external audits.
- Implemented automated systems to improve accuracy and efficiency of engineering processes
- Developed planning criteria for integrating and enabling new technologies
- Established quality control processes to minimize errors and ensure consistent product performance standards
- Analyzed and interpreted customer requirements to develop engineering solutions
- Interacted with subject matter experts to develop training material and tools for personnel
- Introduced advanced analytical tools for data-driven decision making, leading to improved operational efficiency
External Manufacturing & Supplier Quality Manager
Johnson & Johnson
10.2021 - 08.2023
- Leveraged a developmental approach to manage a team, collaboratively identifying, and implementing training and growth opportunities to help further their career
- Directed contract manufacturing and 3PL operations across the globe to ensure regulatory compliance with Quality Systems Requirements, Medical Device Industry, Quality Standards, FDA & EU MDR regulations, and other applicable regulatory agencies, while striving for continuous improvement
- Oversaw Supplier performance monitoring program and Key Process Indicators to identify suppliers requiring development and improvement to ensure First Time Quality and compliance with Quality Agreement requirements
- Partnered with procurement and other cross functional teams on the supplier selection and qualification process
- Analysed quality metrics to identify major site quality risks, leveraging metrics to design strategies for the supplier quality engineering department
- Provided guidance and leadership for component and finished good validation and qualification activities to assure successful adoption of sites changes, including material, process and inspection changes (PPAP, IQ, OQ, PQ, TMV)
- Developed and retained a diverse, highly qualified staff; provided ongoing mentoring and performance feedback
- Set goals which aligned to department plans and directed the execution of goals through coaching and mentoring
- Represented Purchasing Controls during internal and external audits (E.g., FDA Inspections).
Staff Engineer, External Manufacturing & Supplier Quality
Johnson & Johnson
04.2018 - 10.2021
- Represented J&J as the quality lead to decrease nonconformance escalation, supply chain disruption and optimizing manufacturing processes throughout the implementation of zero-defect line concepts, training within industry, critical to quality cascade and other six sigma and lean manufacturing tools
- Guided cross functional teams to oversee root cause analysis investigations, remediation projects, component and process qualifications, end-to-end external manufacturer operations and establishing KPI metrics to monitor the effectiveness of all those initiatives.
Sr, Quality Systems Engineer
Obalon Therapeutics
01.2017 - 03.2018
- Directed Post Market Surveillance (Customer Complaint, Adverse Event Reporting), Product Impact Assessment (also known as Health Hazard Evaluation) and CAPA Processes to ensure compliance with GMPs & applicable worldwide regulations
- Coordinated preparations for regulatory agency inspections, as applicable
- Accompany regulatory agency officials conducting inspections of facilities or operations in supported areas, including GMP Certification inspections and issue formal reports of inspection activities
- Authored health hazard evaluation complying with ISO14971:2012 and conveyed escalation to the Risk Management Board to determine if nonconformances required field action
- Established, monitored, and analyzed key performance indicators (KPIs) to measure effectiveness of complaint handling & CAPA program
- Reduced customer complaint cycle time from 49 calendar days to 27 calendar days.
Complaint Handling & Risk Management Leader
Becton Dickinson (BD)
04.2015 - 01.2017
- Monitored Nonconformance Key Process Indicators, and proactively identified and escalated potential risks to drive continuous improvement, utilizing the Complaint Handling and Health Hazard Evaluation Process
- Authored health hazard evaluations according to ISO 14971 and conveyed product escalations to Risk Management Board/Quality Review Board to determine if nonconformance requires field action
- Orchestrated the creation and update of site risk management files such as pFMEAs, dFMEAs and User FMEAs
- Participate in Field Action Strategy Planning and Execution
- Completed in process assessment to identify potential sources of nonconformance and drive preventive actions to completion.
Principal Quality Engineer
Smiths Medical
03.2014 - 03.2015
- Ensured compliance to relevant standards as well as ensured business needs were met through effective validation, vigilance, and post-market activities
- Led the performance of internal and external nonconformance investigations and provided input to Management Review at business unit level with input into business unit and Executive Management Review
- Conducted periodic product and process assessment to ensure staff is complying with internal procedures
- Authored and approved process, testing and product qualification protocols as required (MVP, IQ/OQ/PQ, First Article Inspection & Test Method Validation)
- Represented quality department to ensure strategies to develop and launch new or improved product were sound and they were meeting Quality System and Stakeholders expectations
- Directed a team of 14 people ranging from technicians to supervisors.
Site Quality Manager
Evenflo
03.2011 - 03.2014
- Directed a team of 30 people ranging from technicians to engineering professionals
- Adopted best manufacturing practices for purchasing controls (Supplier selection, qualification, monitoring & issue resolution)
- Assured development of, and adherence to meaningful Quality Assurance specifications for all raw materials, intermediates, and finished products; Assured compliance to Evenflo policies and directives and current Good Manufacturing Practices (GMPs)
- Provided Quality Assurance approval systems for new product being introduced, data reviews, raw material changes, process changes, and other similar processes
- Mentored and coached workforce diversity and company employee training and development programs
- Guided cross-functional teams to ensure adequacy of internal and external nonconformances
- Chaired material review board for quarantined material
- Developed and maintained Product History File, which consisted in Process Flow Chart, pFMEA, Control Plan, First Article Inspection, Bill of Materials, Manufacturing Procedure and Quality Procedures.
Education
Master of Science - Systems & Industrial Engineering Processes
Centro De Ensenanza Tecnica Y Superior
Tijuana, MEXBachelor of Science - Business Administration
UABC
Tijuana, MEXSkills
- Decision Making
- Talent Development
- Strategic Thinking
- Negotiating
- Communication
- Problem Solving
- Change Agent
- Statical Analysis
- Supplier Development
- Risk Management
- Six Sigma Expert
- Root Cause Analysis
Accomplishments
- Eliminated 100% of Product Escalations (HHEs & Field Actions); 80% of Customer Complaints & 50% of manufacturing related Nonconformances by developing the end-to-end operations of the largest J&J Vision External Manufacturer as the Person-in-Plant.
- Eliminated the major source of site nonconformities, resulting in a cost avoidance of 1.2M USD per fiscal year and significantly increased customer satisfaction.
- Directed supplier certification strategy which streamlined quality inspection for over 1k SKUs, resulting in an annual Head Count avoidance of +500k USD, Increased cash flow by eliminating over $2M in backorders and reducing inspection lead time by 7 days.
- Six Sigma Master Black Belt by International Six Sigma Institute
- Certified Quality Engineer by Johnson & Johnson
- Plastic Technologies & Scientific Injection Molding by Applied Chemical Investigation Centre
Timeline
External Manufacturing & Supplier Quality Manager
Johnson & Johnson
10.2021 - 08.2023
Staff Engineer, External Manufacturing & Supplier Quality
Johnson & Johnson
04.2018 - 10.2021
Sr, Quality Systems Engineer
Obalon Therapeutics
01.2017 - 03.2018
Complaint Handling & Risk Management Leader
Becton Dickinson (BD)
04.2015 - 01.2017
Principal Quality Engineer
Smiths Medical
03.2014 - 03.2015
Site Quality Manager
Evenflo
03.2011 - 03.2014
Supplier Quality Engineering Leader
Johnson & Johnson
8 2023
Master of Science - Systems & Industrial Engineering Processes
Centro De Ensenanza Tecnica Y Superior
Bachelor of Science - Business Administration
UABC
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