Salt Lake Quality Engineer

OMER BAHASAN

Jeddah, Saudi Arabia • ****.*******@****.*** • 050-***-****

EDUCATION

Bachelor of Science, Biomedical Engineering/ Minor, Business Administration May 2019 The University of Utah Salt Lake City UT, USA

EXPERIENCE

Quality Engineer January 2019 - May 2022

COHEREX Medical, Biosense Webster Inc., JnJ Salt Lake City UT, USA Main Projects

- Establishment of Duplicate Production Line: Spearheaded quality initiatives for a duplicate production line to expand manufacturing capacity for Class III medical devices. Directed IQ/OQ/PQ validations, process risk assessments (pFMEA), and streamlined inspection workflows, achieving a 20% improvement in operational efficiency and reducing inspection cycle time by 15%.

- Resumption of Clinical Trials After FDA Regulatory Hold: Collaborated with senior SMEs of Clinical, R&D and Regulatory departments to investigate and resume New Product Development clinical trials following a regulatory hold. Led root cause analysis and risk assessments, collaborated with R&D to redesign critical components and authored remediation reports for FDA submission which led to restoration of trial integrity enabling on-schedule PMA submission.

Professional Experience

• Supervised operations compliance with all related procedures, instructions and the Quality Manual and the adherence to ISO 13485 and FDA CFR 820

• Led comprehensive failure investigations by employing root cause analysis methodologies, effectively identifying and addressing non-conformances and audit observations

• Collaborated with cross-functional teams, including Quality Assurance, Engineering, and Regulatory Affairs, to develop targeted corrective and preventive actions that aligned with FDA regulations and internal quality standards.

• Monitored and surveilled the implementation and effectiveness of corrective actions, achieving a 30% reduction in recurrence of identified issues and enhancing overall product reliability.

• Prepared detailed CAPA reports that documented findings, actions taken, and effectiveness evaluations, ensuring compliance with internal procedures and all regulatory requirements.

• Designed and developed test protocols and participated in performing Verification and Validation activities according to the established company’s procedures and per FDA regulation for medical devices

• Managed a Risk-Based project with a cross-functional team to improve reduce product inspection time without impacting product quality and achieved a significant 80% overall time reduction

• Conducted comprehensive internal audits in accordance with ISO 13485 and FDA regulations, ensuring compliance with quality management systems and identifying areas for improvement.

• Developed and implemented audit plans, including scope definition, resource allocation, and timeline management, resulting in timely completion of all audit activities.

• Participated in cross-functional teams in external audits, collaborating with regulatory bodies and third-party auditors to facilitate smooth audit processes and address findings. Project Manager May 2022 - Now

Bahasan Trading Company LTD. Jeddah, Saudi Arabia

Project: Development of Medical Warehouse (3PL)

- Led end-to-end development of a 2500 sqm medical warehouse with a $2.5M budget, overseeing cross-functional teams of 15+ (designers, contractors, regulatory specialists).

- Spearheaded compliance with SFDA, GDP (Good Distribution Practices), and ISO 13485 standards, securing operational licenses within 6 months through rigorous documentation and facility validation.

- Designed and implemented a Quality Management System (QMS) to streamline workflows, including SOPs for inventory tracking, temperature-controlled storage (2–8 C), and audit readiness, reducing compliance risks by 40%.

- Deployed a cloud-based Warehouse Management System (WMS) integrated with IoT sensors for real-time monitoring of stock levels, expiry dates, and environmental conditions, cutting processing errors by 25%.

- Optimized storage capacity by 30% through layout redesign and vertical racking systems, adopting a FIFO approach for perishable pharmaceuticals.

- Mitigated project risks via contingency planning, resolving permit delays and supply chain bottlenecks, ensuring on-time launch within 5% of the approved budget.

- Coordinated with external stakeholders, including SFDA auditors, logistics partners, and IT vendors, to align technical and regulatory requirements.

TECHNICAL SKILLS

Quality Management Project Management

Facility Management Regulatory Compliance

Product Development Quality Operations

Risk Management Process Validation

Statistical Analysis Medical Device Design Control

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