Julio Dominguez
San Bernardino,CA
Summary
I am an accomplished and detail-oriented Medical Device Quality Engineer with extensive expertise in FDA 21 CFR Part 820 and ISO 13485 standards. I am seeking remote, hybrid, and on-site opportunities to leverage my knowledge in the field of quality engineering, with a willingness to travel and relocate as needed. My career features a proven track record in implementing quality engineering systems and conducting inspections, testing, and audits to ensure regulatory compliance and maintain high-quality standards. I excel in identifying and mitigating risks associated with medical devices, prioritizing patient safety. My strong communication skills and collaborative approach foster cross-functional teamwork and drive continuous improvement. I am committed to staying updated on industry trends and regulatory changes to contribute effectively to any medical device organization.
Overview
14
14
years of professional experience
Work History
Quality Engineer 2
D&k Engineering
Escondido, CA
09.2022 - Current
- Coordinating risk management activities
- Assure compliance with hardware and software development SOPs applied at a project level
- I work with Engineering and Supply Chain to define part quality plans at a component level
- Represent Quality in planning, design, NPI, and production process development on product development teams
- Ensuring process improvement activities remain in compliance with FDA/ISO regulations/standards/guidelines and customer requirements
- Lead or participate in internal/external Quality System audits
- Provide scope of work & direction to the Program Quality Analyst
- I review changes to products in production for reliability impact to aid in the correction process, design or material problems
- Oversee manufacturing process qualification activities and ensure compliance with relevant standards and procedures; create and/or review Manufacturing Qualification Plans and Reports as required
- Lead problem-solving efforts, including customer complaint investigation and analysis to identify and resolve sporadic and chronic quality issues to ensure production of safe and effective products
- Oversaw the development of quality control documentation, including test procedures and inspection criteria
- Maintained up-to-date knowledge of industry quality standards and regulatory requirements.
- Performed data analysis to identify root causes of quality issues and developed corrective actions.
- Facilitated continuous improvement projects focused on reducing waste and increasing efficiency.
- Maintained records of all products manufactured in accordance with documentation requirements.
- Coordinated with external quality auditors during annual audits and assessments.
- Conducted regular quality audits and assessments to ensure adherence to quality management systems.
- Demonstrated strong knowledge of company standards and protocols during inspections.
- Developed and maintained Quality Assurance procedures in accordance with ISO 9001 standards.
Senior Quality Assurance Analyst
Reflow Medical
San Clemente, CA
01.2022 - 08.2022
- Review and approve program non-conformances (NCR) & material review board (MRB) dispositions
- Work with Supplier Quality, Procurement, and/or external suppliers to review, approve, monitor, and update Supplier Control Plans, Tool JD Transfer Plans, and Part Qualification Plans for assigned programs
- Reviewing Made-to-Print specifications with Engineering and D&K Inspection, provides guidance to D&K Inspection a Programʹs Part Quality Plans
- Helping to establish Program Manufacturing Quality Metrics
- Reports Program Manufacturing Quality Metrics to stakeholders
- Working with Program Managers/Project Teams to evaluate design/system requirements, support trace matrix development and updates, and establish appropriate test plans
Quality Control Technician 3
SeaSpine Inc.
Irvine, California
01.2021 - 12.2021
- Inspected incoming material for conformity to established requirements prior to acceptance into inventory
- Verified conformance of parts using statistical sampling techniques such as ANSI and ASQ Z1.4
- Proficient in performing inspections and testing at various production stages
- Inspects and tests: Raw materials, Sub-assemblies, Final Assemblies
- Ensures product quality and conformance to specifications
- Adheres to procedural requirements
- Monitored daily performance of production team to identify and address issues affecting quality product output
- Investigated supplier problems associated with defective materials received from outside vendors in order to determine root causes of failure
- Developed corrective action plans when needed to resolve quality issues
- Reviewed engineering drawings and technical documents for accuracy and completeness prior to release for manufacturing use
- Completed data capture forms, equipment logbooks or inventory forms to support testing procedures
- Identified and troubleshot equipment problems
- Identified areas of improvement in existing processes to increase efficiency
- Analyzes problems related to product quality
- Determines appropriate problem-solving techniques
- Exercises judgment in selecting suitable solutions
Quality Assurance Technician
Advanced Sterilization Products (Johnson & Johnson)
Irvine, CA
04.2020 - 12.2020
- Assisting engineers with handling documentation and solve any device discrepancies
- Proficient performing inspections and testing at various stages of production of the product - from raw materials, sub-assemblies, and final assemblies to assure product quality and conformance to specifications and procedural requirements
- Analyzes problems, determines problem-solving techniques and exercises judgment in selecting appropriate solutions
- Performed regular maintenance checks on laboratory equipment used for testing purposes
- Supported continuous improvement initiatives by analyzing performance data and recommending process enhancements
- Inspect products to ensure that they meet quality standards
- Create tests for quality control of products
- Disassemble product parts to inspect them individually
- Monitor production operations to ensure conformance to company specifications
- Direct assembly adjustments to ensure operations reflect quality standards
- Ensure products meet customer expectations based on company objectives
- Communicate the results of inspections and put forward corrective suggestions
- Write reports to document deficiencies and errors of products
- In charge of generating and investigating non-conformances
Production Lead/Inventory Control Clerk
DHL Johnson & Johnson
Fontana, CA
04.2013 - 06.2020
- Perform safety observations including follow ups and coaching
- Complete onboarding training for new hires
- Lead pre-shift meetings
- Implement corrective procedures for issues
- Identify problem areas and makes suggestions to management
- Ensures compliance with all Occupational and Health safety standards
- Effectively accomplishes objectives
- Monitors team progress
- Completes equipment certification/re-certification
- Collaborated with other departments to ensure smooth operations.
- Executed and coordinated employee training to meet quality requirements.
- Reported problems or concerns with quality, processes, equipment, materials and labor to supervisor.
- Analyzed data from past production runs to identify trends or issues.
- Investigated customer complaints regarding product quality or defects.
- Reduced health and safety risks with strict adherence to safety protocols and PPE requirements.
- Classified defects from finished orders for record tracking and statistics.
- Worked closely with management team to develop long-term plans for growth.
Operations Supervisor (interim)
Tyco Electronics
08.2015 - 12.2015
- Manage logistics and scheduling for carrier pickups, ensuring that all operations run smoothly and efficiently
- Managed scheduling and staffing, optimizing labor costs while ensuring operational demands were met
- Conducted regular performance evaluations, providing feedback and development opportunities to staff
- Conducted regular meetings with staff members to discuss any issues or concerns they may have had
- Reviewed employeesʹ work to check adherence to quality standards and proper procedures
Material Handler/Forklift Operator
DHL Johnson and Johnson
Fontana, California
09.2010 - 04.2013
- Inspected incoming shipments for damage or discrepancies
- Directed items according to established routing schemes using computer-controlled keyboards and scanning equipment to assist mail-sorting processes
- Collaborated with team members to meet daily production goals
- Protected company inventory by maintaining and organizing storage areas
- Disposed of debris and hazardous materials properly to avoid contamination
- Operated forklifts, pallet jacks, and other material handling equipment
- Adhered strictly to company policies concerning the use of protective gear while on duty
- Maintained accurate inventory records of all received items
- Organized warehouse shelves, racks, and bins for proper storage of materials
- Sorted cargo for accurate shipment to target locations, preventing unnecessary delays, and promoting productivity
Education
Bachelors of Science - Business
University of Phoenix
Ontario, CAHigh school diploma -
San Bernardino High School
San BernardinoSkills
- Quality Management Systems
- FDA 21 CFR Part 820 & ISO 13495 Standards
- Document Control
- Risk Management
- Root Cause Analysis
- Cross-Functional Collaboration
- Process Improvement
- Technical Documentation
Timeline
Quality Engineer 2
D&k Engineering
09.2022 - Current
Senior Quality Assurance Analyst
Reflow Medical
01.2022 - 08.2022
Quality Control Technician 3
SeaSpine Inc.
01.2021 - 12.2021
Quality Assurance Technician
Advanced Sterilization Products (Johnson & Johnson)
04.2020 - 12.2020
Operations Supervisor (interim)
Tyco Electronics
08.2015 - 12.2015
Production Lead/Inventory Control Clerk
DHL Johnson & Johnson
04.2013 - 06.2020
Material Handler/Forklift Operator
DHL Johnson and Johnson
09.2010 - 04.2013
Bachelors of Science - Business
University of Phoenix
High school diploma -
San Bernardino High School