DEREK CHENG

*** * ***** ** **** of Prussia PA ***06 · 516-***-****

ad2u6x@r.postjobfree.com

Accomplished quality leader seeking a career focused in operations and process improvement.

EXPERIENCE

APR 2020 – PRESENT

QUALITY ENGINEERING MANAGER, SR CONTINUOUS IMPROVEMENT MANAGER, medical components (medcomp) (harleysville, pa)

Manage and lead CAPA review board meetings to maintain a monitor corrective action status.

Support onsite maintenance of Quality Management system with internal and external audits (Notified Bodies, FDA, customers)

Conduct Quality Reviews on Change Requests, validation protocols, design and development documents.

Established the use of metrics and targets for departmental Management review.

Lead Quality Management System Plans

Support maintenance of KPIs for monthly, quarterly, and Management Review.

Key Successes:

Managed, mentored and empowered five direct reports for continued professional development.

Implemented a new scrap codes project resulting in the identification and reduction of $100,000 inaccurate scrap annually.

Conducted a Kaizen on the Change Request process resulting in a reduction of reapprovals from 75%+ to 6%

Coordinated the implementation of second source Sterilizer with testing and notification to the Notified Bodies.

Reduced MRB disposition timeframe from average of 25 days to 10 days.

Implemented the use of barcode scanners to reduce typo errors.

Lead an IT Help Desk Project to reduce cycle time with proper allocation of resources and triage.

Implemented a new process flow for Private Label products into Medcomp’s portfolio.

JAN 2018 – APR 2020

QUALITY ENGINEER, SUPPLIER QUALITY ENGINEER, desktop metal (burlington, ma)

Implementation of Quality Management Systems (document control, supplier corrective actions, inspection standards etc.).

Lead 6S efforts to improve communication, visual aids and organization.

Assisted in Gage RxR with Laboratory Test and Inspection equipment to validate data integrity.

Lead machine to machine variability study with cross functional engineering and material teams.

Established vendor quality requirements for approval and qualification.

Established Supplier Corrective Action Reporting system to track external escapes.

Utilized statistical tools to validate machine capability and variability.

Key Successes:

Implemented onsite calibration

Implemented Document Management System

Implemented the use of the FARO Portable CMM arm.

Assisted in bringing vendors to ISO 9001 standards through onsite audits.

JUL 2016 – DEC 2017

MANUFACTURING QUALITY ENGINEER, ge aviation (lynn, ma)

DCMA lead for TPMO value stream, managing audit scheduling, record retention and material traceability.

Successfully facilitate MRB material for repair and rework.

Managed and implemented root cause corrective actions for manufacturing escapes.

Facilitate product dispositions to meet delivery demands.

Established vendor quality requirements for approval.

Supported the manufacturing floor for any quality issues and qualification of operators.

Key Successes:

Implemented Cell Control Centers for improved production communication.

Reduced aged WIP by $1.5 million+ dollars.

Implemented cost out projects leading to $90,000+ dollars annually.

JUN 2012 – JUN 2016

QUALITY ENGINEER, greene tweed & co. (kulpsville, pa)

Quality Management Systems lead for Synthetic Value stream, managing technical documents, work procedures and record retention.

Successfully lead and managed customer facing and industry audits (AS9100, NADAP) ensuring compliance and conducting sustaining root cause and corrective actions.

Lead internal auditor, auditing cross functional areas within the company.

Conducted measurement studies leading to the implementation of standardized training initiative for visual defect inspection

Implemented interdepartmental control plan for new tools, ensuring that unapproved tools are not run for production parts through SAP system blocks and physical quarantine.

Key Successes:

Created PFMEA to manage risk and identify opportunities for continuous improvement projects resulting in the kick off and completion of a remake reduction project, saving the company year to date $30,000 dollars of remakes per quarter.

Implemented automated dimensional inspection device in conjunction with an electronic data collection system to reduce inspection cycle time and improve accuracy of measurements.

Lead Lean Six Sigma Project on the reduction of redundant inspection in the QC area resulting in an annualized savings of $150,000+ dollars.

Utilized process capability analysis to reduce AQL inspection for finished products resulting in $50,000 dollars of inspection annually.

Organized and streamlined Customer Returns Room using 5S methodology. Reducing the number of occurrences of lost customers returns from 5+ monthly to zero and improved cycle time of responses to customer complaint from average of 45+ days to an average of 22 days sustained over 3 years.

JUN 2012 – JUN 2016

QUALITY PROCESS ENGINEER, sps technologies (santa ana, ca)

Collaborated with engineers to meet NADCAP and AS9100 certification requirements as an internal auditor in order to update current procedures and implement new improvements in areas such as document control and process analysis.

Managed process improvement project to reduce customer return cycle time, by establishing review process that eliminates backlog of inventory due to delays. This led to a 50% reduction on parts returned in stock.

Utilized Process FMEA analysis to facilitate risk mitigation of primary processes to prioritize needs for improvement to minimize effects of procedural failures.

Key Successes:

Implemented a robust calibration system with a positive recall and tracking system of all company tools resulting in a 3-4 week turn around for calibration of tools down to 1 week.

Executed SPC controls to observe and analyze process variation in key characteristics of the bolts product, resulting in reduced variation in the process and fewer process changes saving tool change over time by 20%.

Conducted a project to reduce the number of customer returns due to administrative errors from 15+ a month to 3 returns a month.

EDUCATION

MAY 2011

B.S. INDUSTRIAL AND MANAGEMENT ENGINEERING, Rensselaer polytechnic institute

• Minor: Economics

• Dean’s List

• Member: Alpha Pi Mu, Sigma Alpha Epsilon, Institute of Industrial Engineers (IIE)

CERTIFICATIONS

ASQ – Lean Six Sigma Black Belt

ISO 9001 Lead Auditor

ISO 13485 Lead Auditor

MDSAP Internal Auditor

AS9100 Rev C Lead Auditor

FAA Designated Manufacturing Inspection Rep (DMIR)

Honeywell Source Certifying Agent

FAA Approved Disposition Authority

SKILLS

Statistical software (Minitab, JMP)

Proficient in Geometric Dimensioning and Tolerance

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