Mohamad Arif Syafiq Bin Mohamad Rohim
Quality Engineer - NPI
Subang Jaya,10
Summary
A Quality Professional with 4.5 years of experience, currently working in medical device manufacturing. Working in an environment adhering to ISO 13485 Quality Management System standards and have expertise in ISO class 7 and 8 clean rooms, internal auditing, quality tools for process monitoring, calibration, measuring equipment, Minitab for Statistical Process Control, and change control. A believer on continuous improvement in daily work to better myself in this field.
Overview
4
4
years of professional experience
3
3
years of post-secondary education
7
7
Certifications
Work History
Quality Engineer - NPI
SteriPack Group
02.2024 - Current
- Established Validation protocols and conduct validation activities upon receiving approval from customer/top management.
- Validation report writing upon completing validation activities and compiling results data.
- Coordinate with Senior QA Inspector for conducting tests from validation activities.
- Employed statistical analysis for validation activities to ensure accuracy of validation process and validates reliability of resulting outcomes.
- Conducted thorough review and analysis of Change Request Reviews (CRR) for various types of changes, such as documentation updates, product modifications, material revisions, and artwork adjustments.
- Lead Change Request (CR) projects involving different level of staffs and departments.
- Created new Raw Material Specifications (RMS) for new products and updated existing RMS as needed.
- Created Product Specifications (PS) and updated existing PS as needed.
- Conducted internal audits to ensure adherence to ISO 13485 standards.
Quality Assurance Operations Executive
Karex Berhad
7 2023 - 01.2024
- Oversee incoming inspection for raw materials done by QA inspectors and consulting with relevant department for any issue regarding incoming goods for goods release
- Control and record the usage of color standard (approved sample) from customer and supplier that serve as reference material during incoming inspection
- Develop Raw Material Specifications (RMS) for all raw materials and update the list for new raw materials or raw materials that have changes in its Certificate of Analysis (COA)
- Issue Non-Conformities Report (NCR) addressing issues at various stages not limited to incoming, in-process, outgoing, finished goods etc
- Liaise with Quality Management System (QMS) department for all NCRs that needed Supplier Corrective Action Request (SCAR) and/or Corrective Action Preventive Action (CAPA) to be raised to supplier and/or internal functions
- Responsible for replying to Customer Complaints Response (CIR) raised by QMS team
- Responsible to reply Corrective Action Preventive Action (CAPA) using QA tools such Fishbone diagram, 5 whys, Root Cause Analysis investigation and Pareto chart
- Review Change Request for all departments that issued Change Request for new changes to be implemented
- Person in charge of 3rd Party sampling
- Liaise with Marketing department and 3rd party inspection bodies for the arrangement of remote or on-site inspection/sampling and the results of sampling
- Initiate, maintain, and liaise with production department on process validation activities and documentation
- Validation done includes software, Excel sheets, chemical, ET machines, foiling machines, packing equipment and production processes
- Prepare validation protocol and report and conduct test for validation samples and monitor test results
- Keeping track of processes that require revalidation (exceeding 10 years since last validation) or validation that was misconducted
- Responsible person to perform arrangement of retest and perform retests on materials that are expiring such as chemicals and foils
- Manage and maintain quality objective activities and compiles department objectives for departments from production function
- Conduct training for QA inspectors and production operator to maintain quality work
- And to conduct training for any revision in Procedure/Work Instruction
- Assist in analysis of quality reports, trend graphs and compilation of data
- Responsible for preparing samples for the marketing department for new customers and for the development of new products
- Keeping track of calibration schedule and liaising with external company to conduct calibration on equipment/machines nearing due date for calibration
- Keeping track of air and surface monitoring requirements and liaising with external companies to conduct the air and surface monitoring
- Conduct Product monitoring by measuring the level of bioburden and protein of products at different production stages.
Quality Assurance Executive
Karex Berhad
09.2021 - 07.2023
- Oversee incoming inspection for all the raw materials and raise Non-Conformance Report (NCR) as records for any non-conformities detected and managed to improve the incoming inspection process by revising related document to ensure better inspection
- Raised Supplier Corrective Action Request (SCAR) for any non-conformities detected from supplier
- Also, responsible for raising Corrective Action Preventive Action (CAPA) for any non- conformities that originated from internal process
- Learn supplier’s processes and able to track recurring or new issues
- Provide assistance to follow up on corrective and preventive actions regarding quality problem, customer complaint or supplier defect
- Control and record the usage of color standard (approved sample) from customer and supplier that serves as reference material during incoming inspection
- Person in charge of 3rd Party sampling
- Consult with Marketing department and 3rd party inspection bodies for the arrangement of remote or on-site inspection/sampling
- Managed to complete sampling on 420 lots for year 2022 and 41 lots as of May 2023
- Initiate, maintain, and liaise with production on process validation activities and documentation
- Learned various processes from the start of dipping process to the end of finished goods
- Did validation for foiling machine, packaging machine, dipping line, and software
- Prepare validation protocol and report and conduct test for validation samples and monitor test results
- Keeping track of processes that require revalidation (exceeding 10 years since last validation) or validation that fails
- Conduct training for QA inspectors and production operator to maintain quality work
- And to conduct training for any revision in Procedure/Work Instruction
- Assist in analysis of quality reports, trend graphs and compilation of data.
Quality Assurance Quality Control Executive
Hexagon Plastic Industries
01.2020 - 08.2021
- Led the QAQC team to ensure good quality products are being produced
- By overseeing the in- process and the final inspection process, defects were able to be detected before being released to the customer
- Participated in determining causes of product defects during in-process with technician team which includes brainstorming session and also doing destructive test on product
- Participated meetings with customers to find solutions for defective products that escape to customer side
- Learned how to communicate and provide solutions to customers with agreed acceptability
- Initiate daily quality meeting with QAQC team for issues that occurred on the previous day and the acceptability of the defects occurred
- Authorized and controlled the release of first piece sample to be used for in-process inspection reference
- Liaise with supplier on received product that does not conform
- Participate in developing product specification for customers.
Education
Bachelor's Degree in Engineering (Electrical/Electronic) -
Universiti Teknologi MARA (UiTM)
Shah Alam, Selangor 09.2016 - 09.2019
Skills
Failure Mode Effect Analysis (FMEA)
Minitab for statistical analysis
Process Validation
Statistical Process Control (SPC)
ISO 13485 Medical Devices
ISO 9001 Quality Management System
ISO 14971 Risk Management for Medical Device
ISO 4074 Natural Rubber Latex Condoms
5 Whys
Root cause analysis
Calibration
Internal Auditing
Change Control
Documentation And Reporting
Measurement tools
Certification
Calibration System for Measuring Equipment
Leadership Experience
Karex Berhad - Assist other sites that are having incoming material issues and provide acceptance criteria for the sites to follow. Led the discussion with management from Thailand site on issue rise from incoming issue that are uncommon on their site., Led the company’s validation activities which the records now are being used for planning future validation activities., Led QA team of 16 QA operator in daily operation.
Steripack Asia - Coordinate with subordinate on carrying out tests from validation activities.
Timeline
Quality Engineer - NPI
SteriPack Group
02.2024 - Current
Quality Assurance Executive
Karex Berhad
09.2021 - 07.2023
Quality Assurance Quality Control Executive
Hexagon Plastic Industries
01.2020 - 08.2021
Bachelor's Degree in Engineering (Electrical/Electronic) -
Universiti Teknologi MARA (UiTM)
09.2016 - 09.2019
Quality Assurance Operations Executive
Karex Berhad
7 2023 - 01.2024