SATHIA RAMAR
Quality Engineer
Kulim
Summary
Experience in medical device, as a Quality Management Representative & Regulatory Compliance Experience in Medical Device as a QA/RA Executive & Medical Lab Technologist. Experience in Quality Engineer (Electronic Industries)
Successful Executive with over 5 years of demonstrated ability in delivering mission-critical results. Offering outstanding communication and cross-cultural team management skills. Entrepreneurial attitude for optimal profitability. Ambitious team leader adept at creating strategic alliances with organizational leaders and effectively aligning with and supporting key business initiatives.
Qualified QA/RA background with proven track record of leading high-performing teams and driving strategic initiatives. Successfully managed large-scale projects and implemented innovative solutions to improve operational efficiency. Demonstrated expertise in financial oversight and stakeholder engagement.
Overview
15
15
years of professional experience
7
7
Certifications
3
3
Languages
Work History
QA/RA Executive
Curas Sdn. Bhd.
01.2018 - 11.2020
- ISO/CE – Assist QA/RA Manager in implementing, maintaining, continuously improving organizational standards and procedure related to ISO/CE.
- Complaints – Handle all customer complaints, investigations as well as initiate and implement corrective action where appropriate under 8D Format.
- Quality Management System (QMS) – Create, update, and maintain Quality Manual, documents, forms and records according to ISO procedure for 9001 and 13485, as well as all international Norms under which the company shall comply through its product commercialization.
- Internal SOP – Maintaining and organizing all SOP’s for all company’s process.
- Internal Audit – Schedule and conduct internal audits on administrative procedure covered by the company’s ISO QMS- External Audit – Coordinate audits with relevant external parties (auditors, regulatory / notified body etc.)
- Trademark Registration – Liaise with Law firm to have trademark registration on the requirement country and region.
- Free Sales Certificate - Involve in the registration of the product with the Authority.
- Class 1 Product registration – Handle registration of the product with the regulatory.
Quality Engineer II
Benchmark Precision Technologies
11.2024 - Current
- Performed quality inspections and drafted reports to detail non-conforming material issues.
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
- Enhanced product quality by implementing rigorous inspection procedures and conducting thorough root cause analysis.
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Developed and implemented quality assurance processes to ensure compliance with industry standards and internal requirements
- Conducted root cause analysis using methodologies like Six Sigma and Failure Mode and Effects Analysis
- Led continuous improvement initiatives to reduce defects and improve product reliability
- Collaborated with cross-functional teams (design, production, suppliers) to resolve quality issues
- Monitored KPIs such as defect rates, yield, and customer complaints
Assistant QA/RA Manager
Duramitt Sdn. Bhd.
01.2020 - 11.2023
- Preparation of Quality Manual, Standard Operating Procedures (SOP), Quality Plan, Product Specification, Risk Management Report (FMEA), Risk Assessment and Technical Files.
- Complaints – Handle all customer complaints, investigations as well as initiate and implement corrective action where appropriate under 8D Format.
- Act as a Quality Management Representative.
- Standard and Regulatory Compliance: Planning and execution of QA strategies and procedures to assure compliance with all applicable international standards (ISO 9001, ISO 13485, PPE Regulation EU 2016/425), current good manufacturing practices (cGMP) requirements.
- Knowledge of FDA 21 CFR Part 820 & Submission.
- Developing and implementing quality management system in manufacturing industries.
- Act as a Document Controller for the company.
- Handle all non-conformance and filling of related documents.
- Manage all external registration requirements to ensure they are met with external bodies on all matters relating to registration.
- Handling all certification, customer, supplier, GMP and other quality related audits.
- Act as internal auditor.
- Design, implement, and improve company quality standards.
- Involve in Calibration and Verification of the equipments.
- Part of Validation Team (IQ, OQ, PQ).
- Analyze data in order to find areas for growth.
- Assist in the recruiting process.
- Training, motivating, coaching, and correcting employees to ensure that standards are met.
- Create reports to track progress - PSS, Excel.
- Review processes in order to ensure that they align with current trends.
Production Executive
Curas Sdn. Bhd.
01.2017 - 01.2018
- Involve in all aspect of relating to research and development of new products. Conduct laboratory tests, risk analysis and evaluation of all products.
- Involve in product development activities and responsible in creating the range product portfolio.
- Take brand ownership and provide brand and product strategies to match up to the global intentions of the brand.
- Compile and update product specifications and all other product reports.
- Coordinate with local hospitals or distributors on clinical evaluation.
- Organize and participate in monitoring market trends, clinical opportunities and monitor competitors’ activities.
- Oversee marketing activities (leaflets, IFU, product presentation, product datasheet, etc) & training materials.
- Review Technical File with QA/RA for adequacy.
- Contribute new and innovative growth strategies for new ranges of medical products.
Healthcare Executive
Malaysia Healthcare Travel Council
01.2015 - 01.2017
- Responsible include keeping records of customer interactions and different transactions, recording details of complaints, comments, and inquiries.
- Always check and ensure that Customer Service follow-up procedures are complete and meet time standards and regulations.
- Fulfilling the weekly, monthly annual accounting requirement.
- Preparing the management monthly and annual report. Generating invoices, monthly claim. Implement and coordinate company’s processes & procedure with different section to ensure efficient operation of the office as a team.
- Act as a Document Controller for the company.
Medical Laboratory Scientist
PATHOLOGY & CLINICAL LABORATORY (M) SDN BHD
01.2011 - 01.2013
- Specimen reception (Accepting, Processing, and sorting of specimens).
- Perform quality control and calibration.
- Analyzes and prepare daily, monthly and yearly quality reports.
- Perform maintenance for machine by daily, weekly, monthly and as needed.
- Perform immunology tests.
- Monitor all devices and facility environment to ensure all work properly in within normal operational standards.
- Laboratory analysis and monitoring of microbial cultures, samples.
- Identify and troubleshoots problem occurs at machine and system.
- Send daily reports and data accurately and timely to HOD.
- Prepare th minutes of meeting.
- Ensure all documents and SOPs are compliance to ISO9001.
- Perform patient results verification and release into system.
- Checking the inventories of the incoming and outgoing reagents and other accessories.
- Conduct in pipette calibration for HQ and branches.
- Assist HOD in external, customer and internal audits.
- Involves in RIQAS and EQA.
- Assist in handling customer complaint.
- Trained newly joined lab assistant.
Education
Bachelor - Biomedicine
Management & Science University
01-2010
Skills
ISO 13485, ISO 9001, ISO14971, ISO15223-1, EUMDR, FDA, PPE Regulation EU2016/425
Regulatory Compliance
Risk Management
Handling of External Audit, Internal Audit, Customer QMS Audit, Social Audit
Customer Complaint - 8D
Postmarket Surveillance & Management Review
CE Application, Technical File Preparation, Product Registration
Quality Assurance & Quality Management
Process Validation (IQ,OQ,PQ)
Certification
IO 13485:2016 Medical Device Quality Management System Training -Curas Sdn.Bhd
Timeline
Quality Engineer II
Benchmark Precision Technologies
11.2024 - Current
Assistant QA/RA Manager
Duramitt Sdn. Bhd.
01.2020 - 11.2023
QA/RA Executive
Curas Sdn. Bhd.
01.2018 - 11.2020
Production Executive
Curas Sdn. Bhd.
01.2017 - 01.2018
Healthcare Executive
Malaysia Healthcare Travel Council
01.2015 - 01.2017
Medical Laboratory Scientist
PATHOLOGY & CLINICAL LABORATORY (M) SDN BHD
01.2011 - 01.2013
Bachelor - Biomedicine
Management & Science University