Umar Malik

About Umar Malik

Customer-focused leader with 20 + years of experience pertaining Medical Device (Class II, Pharma/ Combination Products/ Biologics / Disposables / Wound Management environment. • Experience in various Global Manufacturing Processes, Production Planning, Labeling, Operation Management, Risk Management, Design for Manufacturing (DFM), Design for Assembly (DFA), Change Control, Lean Manufacturing, Process Excellence, Advance Product Quality Planning (APQP), Global Performance Standards, and Device-Drug Master Records • Enterprise Experience in developing, establishing and implementing Quality Management Systems, Supplier Management, Value Engineering, 3PL management, Change Management Systems, Design Control, Management Reviews, Quality Assurance, Device Life Cycle Management, Project Management, Complaints, MDRs, post-marketing surveillance studies, and AE reporting.• Worldwide knowledge/experience with FDA Quality System Regulations (21 CFR Part 820), Good Manufacturing Practices (21 CFR 210-211), CFR 806, 807; ISO 13485, ISO 14971, GAMP 5, TUV, IPC, Canadian (CMDR), EU (MDD), CMDCAS, JPAL, TGA, BfArM, Eudralex, MHRA, IPC, ANVISA, ICH, QbD, USP, NDA, and cGCP. • Performed extensive audits for Drugs, Medical Devices, Vaccines, Pharma products and Sterile GMP audits of raw material suppliers, drug fabricators, APIs, EM sites, packagers and testing laboratories throughout North America, Europe, Asia Pacific, South Africa and Middle-East.• Proven experience in managing large teams globally, honing talent by focusing on, and refining, core competencies and skills, and help create personal and professional growth opportunities. • Strong background in Statistical Techniques and Hands-on experience in Taguchi Methods, Robust Design Methods, Hazard Analysis, Reliability Estimation, Accelerated Testing, HASS, FRACAS, DOE, SDLC process, and Six-Sigma.

Experience

1. Global Head Sterilmed, Quality & Compliance Operation Excellence

   Johnson & Johnson MedTech

   Mar 2018 — Present · Plymouth, MN, US

   Designed and developed the quality and operational excellence program at Sterilmed, a Johnson & Johnson Company. • Managed the implementation of quality management systems, ensuring compliance in device manufacturing and testing. • Led initiatives in risk management and equipment qualification to enhance product reliability and safety.

Education

• Bachelor's of Science: Industrial Engineering

  Industrial and Manufacturing Engineering

  1993 — 1996

• Massachusetts Institute of Technology

  Executive Leadership Program , Strategy and Innovation

  2020 — 2021

• Master's of Science: Quality Engineering / Engineering Management

  Quality / Reliability Engineering / Engineering Management

  2000 — 2002

Skills

• Design Control
• Validation
• Design of Experiments
• Manufacturing
• Quality Management
• Root Cause Analysis
• Black Belt
• Supplier Quality
• Iso 14971
• Fmea
• Quality Control
• Gmp
• Medical Devices
• Capa
• Iso
• Fda
• 5s
• Lean Manufacturing
• 21 Cfr Part 11
• Product Development
• Six Sigma
• Quality Auditing
• Quality System
• V&V
• Continuous Improvement
• Apqp
• Dmaic
• Failure Analysis
• Engineering Management
• Minitab
• Cqe
• Design for Manufacturing
• Reliability Engineering
• Gage R&R
• Ppap
• Kaizen
• Spc
• Process Capability
• Iso 13485