Project Manager Management

Omer Bahasan

****.*******@****.*** +966********* linkedin.com/in/omer-bahasan/ Jeddah, Saudi Arabia

Profile

Result oriented and compliance-focused Project Manager with more than 6 years of experience in Project Management and Quality Management. Possesses extensive knowledge and proven resilience in upholding compliance with internal Quality Management System standards as well as local regulatory requirements. Has a strong track record of leadership within cross-functional teams, enhancing manufacturing and supply chain operations, and achieving notable results in highly regulated environments, particularly during times of urgent business adversity. Expert in agile and waterfall project management methodologies, skilled in leading cross-functional teams, managing stakeholder relationships and driving continuous improvements. Demonstrates agility in project strategic planning, making analytical data-driven decisions, and leveraging digital tools to enhance operational excellence.

Professional Experience

Project Manager - Biomedical Engineer

Bahasan Trading LTD

May 2022 – Present Jeddah, Saudi Arabia

Directed a 15-member team to develop, secure Local Regulator approval and launch operations of 3000 sqrm medical warehouse within 18 months valued 10M SAR

Managed project timelines, budgets and resources ensuring seamless project development exceeding expectations

Developed, implemented and maintained a Saudi FDA / ISO 13485-compliant Quality Management System for medical warehouse operation, enabling compliant distribution of 10M+ SAR pharmaceuticals and medical devices annually with zero regulatory violations

Led preparation for 5+ Saudi FDA and ISO 13485 audits, achieving 100% compliance across GMP, GDP, and SFDA storage/distribution regulations

Conducted in-depth technical analysis of client Supply Chain operations to identify inefficiencies and propose logistical solutions to accelerate client order fulfillment by 25%

Quality Engineer

Biosense Webster Inc, Johnson and Johnson

Feb 2019 – April 2022 Salt Lake City, USA

Supervised Production and Manufacturing Processes ensuring compliance with internal QMS standards, policies, and procedures, including adherence to FDA, ISO 13485, and (GMP) for cardiovascular implant from raw material receiving up to batch releasing

Investigated 50+ process deviations and nonconformances, slashing repeat deviations by 40% through enhanced process controls and staff retraining programs according to internal QMS ensuring all CAPAs are timely completed effectively and efficiently

Prepared and executed process validations (IǪ/OǪ/PǪ) for new production lines, reducing inspection cycle time by 25% through Lean Six Sigma optimization

Developed and updated quality documents in accordance to GDP and internal QMS policies to ensure consistent implementation of quality document change controls and compliance to updated regulations fostering a culture of excellence and continuous improvement

Led internal audits achieving zero major findings in 3 consecutive audits and conducted 15 external 3rd party supplier audits according to QMS policies and procedures

Collaborated with R&D, Clinical, and Regulatory Affairs SMEs to remediate FDA-held clinical trials, including discussion with healthcare professionals on protocol training

Skills

Quality Management System, Agile Framework, Regulation Compliance, Project Management, Risk Management, Data Analysis, Performance Management, Good Manufacturing Practices, SAP, Governance, Good Documentation Practices

Education

2014-2019 – Bachelor of Science in Biomedical Engineering at the University of Utah

Certifications

Project Management Professional (PMP) – Anticipated Oct 2025

Member of Saudi Council of Engineers

University of Utah Dean’s List

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