Please complete the CAPTCHA to continue
@its.jnj.com
✓
LinkedIn matched
A concise factual answer block for searchers comparing this professional profile.
Umar Malik is listed as Customer-Focused leader with proven record of accomplishments in Quality Management, Business Analysis, Manufacturing, and Process Excellence Systems pertaining Med. Devices / Pharma / Combination Products / Disposables at Sterilmed, a Johnson & Johnson Company, based in Easton, Pennsylvania, United States. AeroLeads shows a work email signal at its.jnj.com and a matched LinkedIn profile for Umar Malik.
Umar Malik previously worked as Regional Head, Quality & Compliance / Operation Excellence at Sterilmed, A Johnson & Johnson Company and Global Quality Systems & Process Excellence Leader at Johnson & Johnson Consumer Health. Umar Malik holds Executive Leadership Program, Strategy And Innovation from Massachusetts Institute Of Technology.
This section adds company-level context without repeating Umar Malik's masked contact details.
AeroLeads found 1 current-domain work email signal for Umar Malik. Compare company email patterns before reaching out.
Customer-focused leader with 17 + years of experience pertaining Medical Device (Class II, III) / 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.
Listed skills include Quality System, Iso 13485, Fmea, Fda, and 35 others.
Company context helps verify the profile and gives searchers a useful next step.
A career timeline built from the work history available for this profile.
Design and develop the quality and operational excellence program which involves managing and leading implementation of quality management systems, device manufacturing, testing, design controls, verification studies, risk management, and equipment qualification.
., ., US
Developed Global Quality Systems and tools to improve efficiencies; including Change Control Process, Product Reliability program, 3-D Printing process, Medical Device Governance, Production Controls, Lean Manufacturing process, Risk Management Program, and Device Center of Excellence. Coordinate cross functional teams and supported regulatory inspections.
., ., US
New Brunswick, NJ, US
Quality Assurance Manager Served as site leader for eight (8) Strategic Manufacturing Sites (Devices, NDA, APIs, Combo) for consumer group; led and supported NPI launches, product release, RM testing, stability studies, APR’s, quality management, and site transfers. Also, ensured compliance with J&J Enterprise and Regulatory Standards.
Raritan, NJ, US
Deerfield, Illinois, US
Dearborn, Michigan, US
Quick answers generated from the profile data available on this page.
Umar Malik works for Sterilmed, a Johnson & Johnson Company.
Umar Malik is listed as Customer-Focused leader with proven record of accomplishments in Quality Management, Business Analysis, Manufacturing, and Process Excellence Systems pertaining Med. Devices / Pharma / Combination Products / Disposables at Sterilmed, a Johnson & Johnson Company.
AeroLeads has found 1 work email signal at @its.jnj.com for Umar Malik at Sterilmed, a Johnson & Johnson Company.
Umar Malik is based in Easton, Pennsylvania, United States while working with Sterilmed, a Johnson & Johnson Company.
Umar Malik has worked for Sterilmed, A Johnson & Johnson Company, Johnson & Johnson Consumer Health, Johnson & Johnson Consumer Pharma Group, Ethicon Endo-Surgery, and Baxter Healthcare.
You can use AeroLeads to view verified contact signals for Umar Malik at Sterilmed, a Johnson & Johnson Company, including work email, phone, and LinkedIn data when available.
Umar Malik holds Executive Leadership Program, Strategy And Innovation from Massachusetts Institute Of Technology.
Umar Malik is listed with skills including Quality System, Iso 13485, Fmea, Fda, Medical Devices, Six Sigma, Iso, and Design Control.
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial Search contacts