Mustafa Alkhatatbih

About Mustafa Alkhatatbih

With over 10 years of work experience, I am a passionate and versatile mechanical engineer who strives to deliver high-quality products and services that meet customer needs and regulatory standards. I hold a master degree in Mechanical Engineering as well as multiple certifications in SolidWorks. In my previous job as a Quality Engineer II at Thermo Fisher Scientific, where I support the development and validation of innovative solutions that improve human health and well-being.In my current role, I leverage my skills in Kneat validation software, change control, and risk assessment to facilitate the introduction of new equipments / products and processes in compliance with medical device regulations. I also provide quality review and approval for process qualification and validation activities, deviations, SOPs, and CAPAs. Additionally, I collaborate with cross-functional teams to conduct internal investigations, audits, and root cause analysis, and implement corrective and preventive actions. I take pride in my ability to apply my mechanical engineering knowledge, problem-solving skills, and attention to detail to ensure the safety, efficacy, and reliability of the products and services that Thermo Fisher Scientific offers.

Experience

1. Quality Engineer Ii

   Thermo Fisher Scientific

   Aug 2021 — Present · Bedford / Chelmsford, MA, US

   Proficient in Kneat Validation Software Configuration, ensuring seamless integration with organizational processes- Experienced in conducting User Acceptance Testing (UAT) to validate Kneat system functionality and ensure compliance- Actively involved in in-class training sessions for Kneat validation software and served as the System Platform Administrator (SME) for three sites, optimizing system performance and ensuring compliance- Skilled in developing comprehensive Standard Operating Procedures (SOPs) for standardized processes- Facilitate risk assessments, dFMEA for new equipment/product introduction, drive action during quality oversight activities to identify potential risks and enhance product quality in compliance with Medical Device Regulations, safety, and business risks- Provide quality review and approval for process qualification and validation activities (IQ, OQ & PQ). deviations, change controls, ECO’s, risk assessments- Supports Internal investigation of Nonconformance, Audit findings, CAPA investigation and Complaints to ensure regulatory compliance- Familiar with ISO 13485 and FDA regulatory requirements and cGMP standards guidelines- Demonstrated excellence in problem-solving, experienced in utilizing statistical techniques to enhance manufacturing quality, and in-depth knowledge of quality principles using tools like Minitab- Proficiently interpreted technical drawings, including PID\'s, electrical schematic diagrams, design drawings, and product specifications- Collaborated with a cross-functional team through all phases of product development to insure successful execution.

Education

• Universal Technical Institute, Inc.

  Associate's degree, Automobile/Automotive Mechanics Technology/Technician

  2010 — 2010

• University of Massachusetts Lowell

  Master of Science - MS, Mechanical Engineering, Dual Concentration: Vibrations, Dynamics & Controls / Thermofluids

  2018 — 2019

• University of Massachusetts Lowell

  Bachelor of Science - BS, Mechanical Engineering / Energy Engineering Minor

  2012 — 2017