Angela Ruiz
Miami,FL
Summary
Organized and motivated employee eager to apply time management and organizational skills in various environments. Seeking mid-level opportunities to expand skills while facilitating company growth.
Overview
6
6
years of professional experience
Work History
Quality Engineer Associate
CPS Products
07.2022 - Current
- Conduct thorough internal audits to ensure compliance with company standards and regulatory requirements
- Lead and support external audit activities, facilitating communication between auditors and internal departments (ISO 9001:2015, CSA, UL, Intertek)
- Perform supplier audits to assess and ensure the quality and compliance of suppliers' processes and products
- Manage and maintain quality documentation, ensuring accuracy, consistency, and compliance with relevant standards
- Oversee the Production Part Approval Process (PPAP), ensuring all required documentation and validation activities are completed
- Apply knowledge of Geometric Dimensioning and Tolerancing (GDT) to assess and ensure precise product specifications
- Oversee the nonconformance program, identifying, documenting, and addressing nonconformances to improve product quality
- Develop and implement corrective actions to address root causes of quality issues and prevent recurrence
- Investigate customer complaints, identify root causes, and develop corrective actions to resolve issues and prevent recurrence
- Manage the Material Review Board (MRB) program, evaluating and making decisions on nonconforming materials
- Address and resolve supplier quality issues, working closely with suppliers to implement corrective measures
- Manage the vendor return authorization program, ensuring efficient handling and resolution of returned products
- Provide support to the production floor by addressing and resolving quality issues in real-time
- Collaborate with engineering teams to solve quality-related problems and implement effective solutions
- Conduct quality inspections to ensure products meet established standards and specifications
- Perform monthly and periodic testing on different equipment and products to ensure quality and functionality
- Lead and participate in continuous improvement projects to enhance product quality and operational efficiency
- Monitor Key Performance Indicators (KPIs) to measure and improve quality performance
- Create and present monthly quality reports to management, summarizing quality metrics and performance
- Oversee the Cost of Poor Quality (COPQ) program, identifying areas for cost reduction and quality improvement
- Manage the calibration program, ensuring all measurement instruments are accurately calibrated and maintained.
Manufacturing Planner
Cosmetic Solutions
04.2022 - 07.2022
- Analyzed bills of material to determine requirements and allocate resources quickly and efficiently
- Supervised production schedules, production quality, and on-time delivery
- Evaluated schedules, orders, and forecasts to plan processes and meet timetables
- Communicated with customers to advise them if their orders are on track and provide OORs
- Ensured work orders are generated in a timely manner to reduce the lead time for supply chain order materials.
Production Planner Scheduler
Intermountain Nutrition
04.2021 - 03.2022
- Collaborated with operations as the primary point of contact to schedule booked sales orders for production processes
- Maintained precise production lead-time information and proactively communicated concerns/risks to meet customer requirements
- Created a master schedule that satisfied customer demand while level loading work to be released to manufacturing and optimizing inventory levels and resource utilization
- Provided monthly capacity planning and expectations
- Coordinated with sales, inventory, procurement, quality, and production to better understand lead times for scheduled items and seek ways to reduce internal lead times
- Advised management and appropriate internal teams of the current and future status of materials supply for existing products, as well as future launches for their respective sites
- Monitored order status, managed WIP areas, location accuracy and inventory discrepancies, manufacturing and program support, and communication support.
Document Control Supervisor
Intermountain Nutrition
04.2019 - 04.2021
- Maintained compliance with regulatory agencies and codes including but not limited to, CFR Title 21 Part 111 & 117, FDA
- Responsible for reviewing and updating company policies and standard operating procedures (SOPs)
- Identified process gaps, determined solutions, and implemented updates to drive efficiency improvements
- Uploaded documents to control sites, tracked transmittals, and coordinated revisions
- Kept documents moving in proper flow by applying strong organizational, planning, and multitasking abilities
- Reviewed and approved master manufacturing records and finished product specifications
- Created process deviations and reviewed and approved change controls
- Supported compliance by ensuring effective use of the company's document control program
- Supported traceability exercises, product trace and recall procedures
- Supported CAPA creation and provided information on deposition decisions for held product
- Managed and supervised a team of 6 people.
Document Control Specialist
Intermountain Nutrition
10.2018 - 04.2019
- Created, revised, and issued master manufacturing records and batch manufacturing records
- Managed label approvals and receiving, monitored label inventory and usage, and staged labels for production.
Quality Assurance Specialist
Intermountain Nutrition
04.2018 - 10.2018
- Followed and enforced company policy on all required GMP products, quality, and food safety requirements
- Ensured high quality of products, services, housekeeping, and hygiene standards in designated GMP areas
- Assisted, advised, and trained production operators in attaining quality standards.
Education
Political Science -
EAFIT University
ISO 9001:2015 Certified Lead Auditor -
Completed coursework in DS-21 CFR 111 Dietary Supplement GMP -
Skills
- Fluent in English and Spanish
- Fast learner, detail-oriented, problem-solving, and multitasking
- ISO 9001 Knowledge
Timeline
Quality Engineer Associate
CPS Products
07.2022 - Current
Manufacturing Planner
Cosmetic Solutions
04.2022 - 07.2022
Production Planner Scheduler
Intermountain Nutrition
04.2021 - 03.2022
Document Control Supervisor
Intermountain Nutrition
04.2019 - 04.2021
Document Control Specialist
Intermountain Nutrition
10.2018 - 04.2019
Quality Assurance Specialist
Intermountain Nutrition
04.2018 - 10.2018
Political Science -
EAFIT University
ISO 9001:2015 Certified Lead Auditor -
Completed coursework in DS-21 CFR 111 Dietary Supplement GMP -
Similar Profiles
Carol BaineCarol Baine
Food Demonstrator at CPS ProductsFood Demonstrator at CPS Products
John CollinsJohn Collins
Educator at Chicago Public Schools CPSEducator at Chicago Public Schools CPS
Blake Hamilton CurrieBlake Hamilton Currie
Substitute Teacher at Chicago Public Schools CPSSubstitute Teacher at Chicago Public Schools CPS
Yennifer NimoYennifer Nimo
Registered Medical Assistant at Guidewell SanitasRegistered Medical Assistant at Guidewell Sanitas
Yvelyne MercierYvelyne Mercier
Assistant Manager at Club SpaceAssistant Manager at Club Space