Nnamdi Omeje
Laurel,MD
Summary
Experienced Quality Engineer with a strong background in managing diverse portfolios within the Medical Device and Pharmaceutical industries. Demonstrated success in effectively engaging Fortune 500 clients and internal stakeholders to discern needs, foster new business opportunities, and deliver exceptional service. Skilled in guiding clients through the design and implementation of global quality assurance programs to ensure compliance and elevate product integrity. Proficient in assessing consulting deliverables, providing technical leadership, and coordinating on-site consulting engagements. Capable of resolving client issues, supporting recruitment initiatives, and optimizing operational processes to enhance client acquisition and retention. Proficient in CRM software utilization and committed to achieving outstanding outcomes within dynamic environments.
Overview
10
10
years of professional experience
Work History
Quality Engineer
RAY-PARKER ICT
Baltimore, MD
03.2023 - Current
- Collaborated with cross-functional teams to qualify new suppliers and new products for production, adhering to developed standards, and ensuring compliance with Quality Management Systems (QMS) requirements.
- Collaborated with cross-functional teams to develop and implement test plans for qualifying new suppliers, products, and equipment. Detailed requirements for machine acceptance runs, Viega Production Approval Process (VPAP), and Supplier Production Approval Process (SPAP). Developed ongoing inspection plans for incoming goods and manufacturing processes.
- Conducted supplier audits and visits to resolve issues, drive process standardization, waste elimination, and continuous improvement.
- Implemented, evaluated, followed up, and assisted with Supplier Corrective Action Requests (SCARs).
- Collaborated with cross-functional teams to monitor, analyze, and report on supplier performance. Led and supported supplier quality improvement teams.
- Established, implemented, and maintained QMS procedures, documents, work instructions, plant standards, and control plans both internally and with suppliers. Followed up to ensure processes and timelines were followed.
- Conducted research and continually developed knowledge of Viega products and systems, including applicable applications, listings, and standards.
- Worked with Purchasing to develop positive relationships and effective lines of communication with suppliers, fostering partnership-oriented arrangements.
- Supported improvement workshops and initiatives to enhance products and processes and reduce costs.
- Assisted suppliers with implementing Advanced Product Quality Planning (APQP), Lean Manufacturing, Six Sigma, or other quality improvement tools.
- Continued to develop knowledge of Lean/Six Sigma project methodologies, including but not limited to DMAIC (Define, Measure, Analyze, Improve, Control), DMADV (Define, Measure, Analyze, Design, Verify), QFD (Quality Function Deployment), FMEA (Failure Modes Effects Analysis), APQP (Advanced Product Quality Planning), value stream/process mapping, associated statistical analysis, and supplier development.
- Attended ASQ and continuing education training to continually develop quality tools, techniques, and systems.
- Reduced product defects by closely monitoring supplier production lines and providing regular feedback for improvements.
- Enhanced supplier performance by implementing stringent quality control processes and procedures.
- Maintained amiable relationships with suppliers through difficult quality control issues, supporting healthy business interactions.
- Actively participated in industry conferences and events to stay abreast of the latest developments in supplier quality engineering, applying relevant learnings to enhance organizational performance.
- Enhanced product quality by implementing rigorous inspection procedures and conducting thorough root cause analysis.
- Reduced production defects by designing and executing comprehensive quality control processes.
Quality Engineer
FIRE SHOT
Florida City, FL
01.2019 - 02.2023
- Provided quality engineering support in the manufacturing of medical devices and hardware.
- Ensured compliance of manufacturing processes and areas to all applicable quality system regulations.
- Led Nonconformance (NCMR) process, including inspection methods, containment, correction, closure, and CAPAs, driving continuous improvement through trend data analysis.
- Monitored and analyzed production information to support risk management and provided direction for corrective and preventive actions or process improvement activities.
- Collaborated with manufacturing engineering to ensure necessary process controls and validations were in place, adhering to Good Manufacturing Practices (GMP).
- Oversaw the inspection and testing of raw materials, components, and finished products to ensure compliance with specifications and quality standards, establishing and maintaining quality control procedures, including inspection methods and test protocols.
- Resolved incoming inspection yield issues by enhancing vendor process capabilities, ensuring internal drawing specifications, and validating inspection methods.
- Led analysis of defective components found in Incoming Inspection, collaborating with suppliers to resolve issues (SCARs).
- Supported internal auditing requirements in manufacturing to ensure compliance with quality system requirements.
- Reduced production defects by designing and executing comprehensive quality control processes.
- Contributed to R&D projects by providing input on manufacturability, quality requirements, and feasibility studies supporting the successful transition from concept to production.
Quality Engineer
Stream Technologies
Texas City, TX
04.2016 - 01.2019
- Enhanced supplier performance by implementing stringent quality control processes and procedures.
- Reduced product defects by closely monitoring supplier production lines and providing regular feedback for improvements.
- Increased overall supplier satisfaction with frequent communication, addressing concerns, and providing support.
- Conducted comprehensive audits of suppliers' facilities to ensure compliance with industry standards and regulations.
- Collaborated with cross-functional teams to identify potential supply chain risks and develop contingency plans accordingly.
- Evaluated supplier proposals, conducting thorough assessments of their capabilities to meet organizational requirements.
- Managed relationships with key suppliers, fostering long-term partnerships that benefited both parties involved.
- Facilitated cross-functional meetings between internal teams and external partners to discuss ongoing projects and address any challenges promptly.
- Analyzed issues with supplier contributions to detect defect trends, reporting findings to appropriate personnel.
- Aided suppliers in raw material selection strategies to encourage superior supply chain outcomes.
Software Quality Assurance Engineer
PURPLE FOX TECHNOLOGIES
Remote, UK
04.2014 - 03.2016
- Improved software quality by designing and implementing comprehensive test plans, identifying bugs, and suggesting improvements.
- Collaborated with developers to ensure timely resolution of identified issues, enhancing overall product performance.
- Streamlined testing processes for faster and more accurate results by automating repetitive tasks using scripting languages.
- Reduced defect rates with thorough manual testing, ensuring all use cases were covered before deployment.
- Enhanced user experience by collaborating with UX designers to identify areas for improvement in software interfaces.
- Ensured compliance with industry standards by conducting regular audits of software development practices and documentation.
- Boosted team efficiency through effective communication and collaboration during agile sprint planning sessions.
- Identified potential risks early in the development cycle, allowing for proactive mitigation strategies to be implemented.
- Optimized test case management through close collaboration with cross-functional teams, ensuring full coverage of requirements.
- Created detailed bug reports complete with reproduction steps, enabling swift resolution by developers.
- Supported successful product releases by performing regression testing on existing features after each update cycle.
- Developed custom test tools to increase efficiency and accuracy of the QA process across various platforms and environments.
- Documented testing procedures for developers and future testing use.
Education
Bachelor of Science - Mechanical Engineering
University of Nigeria
ENUGU STATE, NIGERIASkills
- Product Design
- Quality Risk Assessment
- Schematic reading
- Prototyping
- Acceptance Activities
- External manufacturing,
- Incoming Quality,
- Corrective and Preventive Action(CAPA),
- Internal and External Audits,
- Customer Relations
- Supplier Qualification,
- Document/record Controls,
- Environmental Monitoring,
- TRACKWISE,
- 21 CFR PART 11,
- Root Cause Analysis
- CATSWEB ,
- Time management abilities
- Process/Test Method Validation/ Equipment Validation, Technology Transfer,
- Nonconforming Product(NCR),
- Quality Management system(QMS),
- GAMP,
- MES(Manufacturing execution system)
- SAP, VEEVA VAULT
- ISO 13485, 21CFR 820
- JIRA
- COMALA
- SCRIPTRUNNER
- WEBDRIVER
- POSTMAN
- Six Sigma Methodologies
Timeline
Quality Engineer
RAY-PARKER ICT
03.2023 - Current
Quality Engineer
FIRE SHOT
01.2019 - 02.2023
Quality Engineer
Stream Technologies
04.2016 - 01.2019
Software Quality Assurance Engineer
PURPLE FOX TECHNOLOGIES
04.2014 - 03.2016
Bachelor of Science - Mechanical Engineering
University of Nigeria