Process Engineer Ii

Location:

Red Oak, TX

Posted:

September 29, 2024

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Resume:

JEFFERY LATIN

E D U C A T I O N

318-***-****

************@*****.***

Dallas, TX

E X P E R I E N C E

MATERIAL AND PROCESS ENGINEER II

Qarbon Aerospace / Red Oak, TX / February 2023 – Present

• Assist with the development and implementation of materials and processes for the Virgin Galactic Delta Class Spaceship manufacturing, ensuring compliance with industry standards, specifications, and safety regulations.

• Conducted process trials creating test panels using BMI Material

• Participated in the selection and qualification of materials, ensuring compliance with industry standards and project requirements.

• Conducted material testing and characterization, including mechanical, and chemical analysis.

• Collaborated with cross-functional teams to optimize manufacturing processes and improve product quality.

• Develop training documents for operators laying up parts.

• Oversee the thermal survey program for both ROF and MVF sites SENIOR COMPLIANCE ENGINEER

Johnson & Johnson Mentor / Irving, TX / January 2021 – February 2023

• Responsible for managing the Internal & External Audit Programs for three sites.

(Irving, Tx: Coppell, Tx: Irvine, CA)

• Lead internal audits applying advanced internal audit techniques including, information gathering, documentation, evaluation, data analysis, and problem- solving skills

• Evaluate production processes for compliance with quality requirements

• Development of audit plans, audit schedules, and audit reports

• Identify processes, situations, etc., where organization is meeting requirements, as well as identify opportunities for improvement

• Lead and managed the backroom over 17 External Audits with different auditing bodies such as FDA, INMETRO, MDSAP, BSI, etc.

• Demonstrated ability to manage & implement multiple large-scale projects with minimal supervision

• Prepares summaries on compliance with assigned regulation(s), regulatory requirements, and/or compliance risks for senior management, and/or Committees/Boards or Executives as required

• Provides advisory services and direction to all business and support areas regarding assigned regulations, regulatory requirements, and/or compliance risks

• Coordinate compliance review activities with external regulatory auditors

• Communicate recommendation and decisions across a wide spectrum of the organization

• Conduct site audits and compile gap analysis against Audit targets

• Implement and facilitate FDA Readiness Activities

• DI Champion for the site and have implemented monthly compliance DI walks that have identified risk

PITTSBURG STATE UNIVERSITY

Master of Business Administration

Concentration: International Business

Pittsburg, Kansas

SOUTHERN A&M UNIVERSITY

Bachelor of Science

Major: Mechanical Engineering

Baton Rouge, LA

Multitasks and meets deadlines

Team Oriented

Technical Skills

AutoCAD, Minitab

Project Planning

Attention to detail

Risk Assessment/Root Cause Analysis

Analytical problem-solving

Lead Auditor

K E Y S K I L L S

C O N T A C T

H O N O R S

American Society for Quality

NSBE

ASME

JEFFERY LATIN

E D U C A T I O N

318-***-****

************@*****.***

Dallas, TX

E X P E R I E N C E

QUALITY OPERATIONS ENGINEER

Johnson & Johnson Mentor / Irving, TX / April 2019 – January 2021

• Responsible for Quality of the warehouse and raw material for all production lines

• Worked directly with Supplier Quality Engineer to ensure material met drawing specifications.

• Ensure accurate incoming inspection through reading part drawings and specifications and measuring samples against the part requirements.

• Investigated defective parts on the assembly line or in the warehouse to confirm root cause of the problem.

• Provided engineering support to manufacturing department ensuring consistent application of quality techniques.

• Resolved quality issues of capability, tolerance, and materials related issues.

• Worked directly with line lead, process engineers, and supplier quality engineer to resolve raw material/supplier related issues.

• Initiated NC’s for Non-Conforming material, out of tolerance or missing assets, and assisted with the dispositioning of components.

• Updated pFMEA’s to define true defect rates during process steps.

• Responsible for tracking and trending SPC seal strength data for thermoforms on a weekly basis.

• Responsible for data collection to support assessments of change control/design control, engineering change requests, deviations/non-conformances, process validation.

QUALITY ASSURANCE ENGINEER

Flextronics Medical Dallas Design Center / Irving, TX / October 2016 - April 2019

• Quality Assurance Engineer for Clinical Trial Bellerophon Therapeutics Inc. and Chrono Company projects

• Performed quality test on mechanical and electrical components.

• Managed operators to make sure good documentation practices and proper quality steps were followed

• Communicated quality issues with customer and suppliers

• Performed incoming and final inspection of products and material.

• Created NCMR's for Non-Conforming devices and material

• Created IPS/FPS documents

• Tracked and trend key figures and quality metrics

• Assisted with complaint investigations and CAPA facilitation

• Reviewed and maintained the Device History Records

• Performed Internal Audits and Supplier Audits

• Assisted with FDA regulatory requirements for FDA audit on the Bellerophon project.