Muhaymin Atih
BSMT
Dammam,Dammam
Summary
Dedicated QA/QC and regulatory affair professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Disciplined and forward-thinking manager with excellent communication and team-building skills.
Overview
29
29
years of professional experience
7
7
Certification
Work History
QA/QC Regulatory Affair Executive
Al-Shifa Medical Products Co. (CJS)
Dammam , Saudi Arabia
2021.03 - Current
- Developed, implemented, and maintained effective quality/regulatory affair systems in compliance with MDD/93/42/EEC, MDR 2017/745, ISO 13485, and SFDA regulations
- Product registration through SFDA GHAD system, MDIL, SPC, and maintained Technical Files for Medical Devices. (Registered about 20 products group class 1 to 3 medical devices)
- Initiate Process validation, sterilization, and cleanroom validation.
- Conduct comprehensive training in quality control procedures and policies to QC staffs and other employees.
- Oversee day-to-day quality control operations, including inspection, testing, and documentation.(tensile test, Penetration, peel, leak, break etc..)
- Ensure strict compliance with applicable regulations, guidelines, and standards, including SFDA regulations, ISO 13485 standards, GLP, and GMPs
- Conduct internal audits to identify non-conformances and opportunities for improvement, collaborating with other departments for resolution
- Investigate customer complaints raised by SFDA-NCMDR and collaborate with other departments for resolution and corrective actions.
- Monitor quality metrics such as defect rates and customer satisfaction, implements improvement plans as needed
- Analyze data related to quality control operations to identify trends, and develop improvement strategies
- Collaborate with cross-functional departments (production, sales, procurement, engineering) to ensure quality standards were met throughout the manufacturing process
- Monitor update with changes in regulations, standards, and industry best practices in medical device manufacturing.
- Supervise the central microbiological and analytical laboratory that conduct tests such as sterility, endotoxin test, BIs, bioburden, water test and other chemical and microbiological tests)
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
- Demonstrated leadership skills in managing projects from concept to completion.
Quality/Regulatory Affair Manager / Lead Auditor
Atlas Support & Services Co. Ltd (Inspection and Certification)
2019.02 - 2021.03
- Administer certification and inspection activities
- Managed accreditation and compliance to ISO 17020 and ISO 17021 with Accreditation bodies (SAC and GAC)
- Conduct certification audits for QMS ISO 9001, ISO 13485 MD, ISO 17025, ISO 14001, ISO 22000, and ISO 45001
- Provided procedural and pertinent advice to the team of auditors
- verify inspection reports and issue inspection certificates
- Participate in the review of audit reports and certification audit reports
- Review applications and created audit plans, forming audit teams
- Correspond with clients regarding applications, quotations, and audit schedules
- Conduct regular internal audits and
- Performed root cause analysis on non-conformities, correcting deficiencies found during audit.
- Conduct training on internal auditors.
- Execute corrective action plans from audit results.
- Provided guidance to auditor/inspector team members to meet business objectives.
Quality Assurance Manager
Al-Saghyir Boiler & Pressure Vessel Co. ltd
Riyadh , Saudi Arabia
2011.04 - 2018.12
- Implemented all aspects of QA/QC, safety, and environmental contingent plans,
- Conducts safety inspections and quantitative risk analysis
- Managed and handled ASME U, S, PP, R stamped for pressure vessels, storage tanks, power piping, and steam boilers. ensure compliance with statutory requirements.
- Maintained and managed the registration of steam boilers with the National Board of Boilers and Pressure Vessels Inspectors
- Maintained and managed the company's quality system in compliance with ASME, ARAMCO, and ISO 9001:2015 standards
- Obtained vendor approvals from clients such as ARAMCO (with SAP vendor#), SABIC, Petro Rabigh, MAADEN, MOWAH, Veolia, etc
- Managed and oversee project quality control inspection to ensure compliance with codes, standards, regulations, equipment-specific specifications, and ISO QMS requirements.
- Review development planning for fabrication, inspection ITP, documentation, and operations activities, including duties within the QA/QC staff and related work schedules
- Supervise all inspection visual and non-destructive testing (NDE), including 3rd party and Authorized Inspectors (AI)
- Established and maintained a quality manual, quality records, and policies in compliance with ASME standards and ISO 9001.
- Review testing strategies based on due dates and project requirements per ASME BPV Code
- Conduct QMS internal audits and identified potential issues in all phases of operations
- Ensure facility compliance with all Corporate Quality Policies, objectives, National Board, ARAMCO, and ASME Standards across all departments through monitoring and spot-checking logs, records, etc
- Established health and safety and environmental program, including training and fire drills.
- Identified trends and assessed opportunities to improve processes and execution.
QA/QC Manager /Regulatory Affair
Qatari-German Co. For Medical Devices
Doha , State of Qatar
2009.03 - 2011.02
- Developed, implemented, communicated, and maintained an effective quality system in adherence to MDD/93/42/EEC, Russian PCT standard, and ISO 13485 standards
- Established and maintained Technical Files for Medical Devices, while also developing and maintaining Quality manuals, SOPs, and work instructions
- Achieved a 20% cost reduction through continuous performance improvement, waste mitigation, and simplification of work procedures in support of products for the international market
- Managed all aspects of the QA staff, including conducting performance reviews, facilitating career development, and providing necessary training
- Closely collaborated with Development and Product managers to estimate test efforts and develop release schedules
- Ensured superior customer satisfaction by handling consumer complaints in a professional manner
- Conducted internal audits and vendor audits
- Developed, reviewed, and approved validation protocols and reports
- Prepare Hygiene Plans and ensured their implementation through Hygiene Audits to meet cleanroom requirements
- Communicate with interrelated departments regarding issues related to Quality and regulatory requirements
- Maintained and implemented Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
- Established and tracked quality department goals and objectives.
- Specified quality requirements of raw materials with suppliers.
QA/QC Manager /Regulatory Affair
Saudi Mais Company for Medical Devices
Riyadh , Saudi Arabia
1995.03 - 2006.04
- Led all aspects of the company's quality system and teams, overseeing quality control and quality assurance activities in compliance with ISO 9001, ISO 13485, MDD/93/42/EEC.
- Collaborated closely with top management and other departments
- Managed medical devices of various classes (Class I, II, Class IIa, Class III)
- Evaluated products for own-brand labeling, including Single-use MD, Packs, drapes, IVD, and kits
- Orchestrated medical device registration with CE mark, and Saudi MOH.
- Establish, implement, and maintain a critical quality management system.
- ensure awareness of most staff on regulations and requirements of a medical device industry.
- Provided technical expertise to support new product development.
- Take lead on Post-market surveillance, process validation, risk management, and supplier evaluations.
- Managed quality assurance programs for the facility, ensuring proper hygiene in personnel, cleanrooms, raw materials, product handling, calibration.
- Product testing/analysis ( in-process and finished products and final release). such as tensile test, leak test, penetration, torque, peel off and other visual tests.
- Initiated Corrective and Preventive Actions (CA/PA) and ensured effective implementation.
- Liaise and communicate with regulatory authorities and notified bodies, including 3rd party auditors.
- Conduct Internal Audits & Management Reviews on a regular basis.
- Supervise the central microbiological and analytical laboratory, conducting activities such as Sterility testing, endotoxin/LAL testing, bioburden testing, calibration, and validation, etc.
- Kept equipment operating and in good condition by performing quality checks and calling in for repairs when needed.
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
- Established and tracked quality department goals and objectives.
- Tracked quality issues with external customers, suppliers, and internal plant operations.
Education
Bachelor of Science - Medical Technology
Universidad De Zamboanga
Zamboanga City06.1994
Skills
- Risk Management
- Quality Management
- Project Planning
- Problem Resolution
- Training and Development
- Change Implementation
- Regulatory affair
- Technical File generation
- SFDA product registration
- CE mark
- MDD/MDR
Academicqualifications
Bachelor of Science in Medical Technology - Universidad de Zamboanga 1990-1994
Relevant coursework: Laboratory Management and control, Microbiology, Clinical Chemistry, Hematology, Instrumentation and Analytical Techniques, Pathology etc.
High School Diploma Claret High School of Maluso 1986-1990
- Graduate with honor
- Leadership Awardee (Gerry Roxas award)
- Most outstanding Student of the year awardee
Certificationstrainingcourses
- IRCA/ CQI Lead Auditor ISO 9001:2015 QMS, ISO 14001:2015 EMS, and ISO 13485:2016
- MDR 2017/745 Training Certificate
- USFDA Regulatory of Pharmaceutical, Biotech and Medical Devices
- ISO 13485:2003, EN46002 & MDD 93/42/EEC
- Certification to ISO 17020 and ISO 17021
- Certificate in Clinical Study Design
- HSE Training Certificate, International Offshore Onshore Oil and Gas, (IADC & IOSH Affiliate)
- ISO 17025: 2005 (Laboratory Competence) training course
- Lean Six Sigma
Iqamanumber
2472644313
Personal Information
- Number of Children: 2
- Date of Birth: 10/24/72
- Nationality: Philippines
- Driving License: Saudi Arabia and Philippines
- Marital Status: Married
Certification
· IRCA/ CQI Lead Auditor ISO 9001:2015 QMS, ISO 14001:2015 EMS, and ISO 13485:2016
· MDR 2017/745 Training Certificate
· USFDA Regulatory of Pharmaceutical, Biotech and Medical Devices
· ISO 13485:2003, EN46002 & MDD 93/42/EEC
· Certification to ISO 17020 and ISO 17021
· Certificate in Clinical Study Design
· HSE Training Certificate, International Offshore Onshore Oil and Gas, (IADC & IOSH Affiliate)
· ISO 17025: 2005 (Laboratory Competence) training course
· Lean Six Sigma
Reading books, exercise and playing tennis.
Reading Books:I have a passion for reading a wide variety of books, ranging specially on theology. This hobby enhances my critical thinking, expands my knowledge, and improves my communication skills.
Exercise:Regular exercise is a significant part of my routine. It helps me maintain a healthy lifestyle, boosts my energy levels, and improves my mental focus. I enjoy activities such as jogging and strength training, which contribute to my overall well-being and productivity.
Playing Tennis:I am an avid tennis player and have been playing for some years. Tennis not only keeps me physically active but also hones my strategic thinking and teamwork abilities.
Languages
Tagalog, Visayan, Tausog, Yakan, Chavacano, Chavacano, Sama
Native language
Arabic
Intermediate (B1)
English
Proficient
C2
Timeline
QA/QC Regulatory Affair Executive
Al-Shifa Medical Products Co. (CJS)
2021.03 - Current
Quality/Regulatory Affair Manager / Lead Auditor
Atlas Support & Services Co. Ltd (Inspection and Certification)
2019.02 - 2021.03
Quality Assurance Manager
Al-Saghyir Boiler & Pressure Vessel Co. ltd
2011.04 - 2018.12
QA/QC Manager /Regulatory Affair
Qatari-German Co. For Medical Devices
2009.03 - 2011.02
QA/QC Manager /Regulatory Affair
Saudi Mais Company for Medical Devices
1995.03 - 2006.04
Bachelor of Science - Medical Technology
Universidad De Zamboanga
· IRCA/ CQI Lead Auditor ISO 9001:2015 QMS, ISO 14001:2015 EMS, and ISO 13485:2016
· MDR 2017/745 Training Certificate
· USFDA Regulatory of Pharmaceutical, Biotech and Medical Devices
· ISO 13485:2003, EN46002 & MDD 93/42/EEC
· Certification to ISO 17020 and ISO 17021
· Certificate in Clinical Study Design
· HSE Training Certificate, International Offshore Onshore Oil and Gas, (IADC & IOSH Affiliate)
· ISO 17025: 2005 (Laboratory Competence) training course
· Lean Six Sigma
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