Imamudeen Ali Email & Phone Number

Singapore

Singapore, Singapore

Singapore, Singapore

Singapore

Oversee ZIG Venture's medical device manufacturing division's quality which includes

• Develop, implement, and maintain quality management systems to assure the quality of products/ services delivered which meets the customer and regulatory requirements.• Review products/ services and processes performance and makes recommendation for improvement • Manage customer’s feedback, complaints, defect/ data/ root cause analysis, corrective/ preventive actions• Work with customer base to resolve quality issues, will assume the role of window person to the customer regarding quality• Develop, install and maintain economic QC sampling plans, procedures/ work instructions for manufacturing• Summarize and present data to Engineering regarding manufacturing, vendor and field complaints. Make recommendations for engineering evaluation toward problem elimination• Facilitates/ participate in PFMEA, FA• Ensure that processes needed for the quality management system are documented• Report effectiveness of quality management system and needs for improvement to top management• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization

Zicom MedTacc Pte Ltd, a SPRING supported Sector Specific Accelerator (SSA), manages a S$30M fund and primarily invests in pre-revenue medtech startups with the aim of achieving profitability within five (5) years. Leveraging on the group’s capabilities, Zicom MedTacc takes a proactive stance in supporting portfolio companies in their product development and market access, thereby reducing time-to-market..Provide quality assurance (QA) guidance & execution for start-ups and assigned group of companies.• Establish, implement & Maintain Quality Management System (QMS) of start-ups and assigned group of companies according to relevant standards (ISO 13485, ISO 9001, FDA Part 21 CFR 820)• Ensures that company third party accreditations are obtained and maintained.• Ensure all company policies, procedures, and work instructions are documented in a clear, simple and concise manner.• Train all company personnel in the documented company policies.• Conducted internal & supplier audits on behalf of start-ups• Control and maintain the company audit and risk assessment schedule.• Ensure personnel have received appropriate training and are assessed as competent to perform tasks.• Prepare and submit monthly management reports relating to company systems, compliance and incidents• Maintain the company library of compliance resources including standards.

Singapore

• Build and lead an effective Quality unit including Quality Systems & Compliance, Quality Validation, Quality Operations and Quality Control with respect to ISO 9001 / ISO 13485 including compliance to FDA 21 CFR Part 820.• Provide leadership, direction and support to the people within Quality and ensure that they’re qualified, competent and motivated to carry out their duties in a safer manner.• Oversee key supplier continuous improvement metrics including the outsourced manufacturing partners.• Plan, Lead and conduct Internal and supplier Audits (system & Process) in accordance to the company’s audit framework (ISO 9001:2008 & ISO 13485). • Responsible for R&D activities related to system Quality.• Lead to ensure new product introduction quality deliverables are created and properly executed (eg. Project quality plan, Risk management plan etc).• Responsible for PFMEA, SPC, Process validation (IQ, OQ, PQ) & Internal/ External CAPA• Support DHF/DMR/DHR content completion, integrity, and regulatory and standards compliance. • Review and approve quality system related process control documentation ensuring compliance with the internal Quality system, Quality system regulation, ISO 9001, ISO13485 and ISO14971.

Singapore

• Key person in driving company to achieve AS 9001• Support all aspects of process engineering for manufacturing of precision components.• Design new mechanical fixtures and modify existing tooling fixture for quality control testing phase.• Developed and introduced improvements to reduced total wastage of material during fabrication by optimizing machining process.• Create package and part labels and inspect all units prior to shipping to ensure all quality standards maintained• Writing and maintaining work instructions, control plans, process flow, and process failure modes effects analysis documents• Training manufacturing personnel as necessary on the use and maintenance of new equipment and processes• Working with manufacturing plant professionals on process integrations with contribute to process development through both individual projects and collaborative team efforts.• Confer with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards• Responsible for implementing PMP for all projects.• Established line and supplier audit.• Optimized process in achieving high yield rate.

• Manage and oversee the quality of Nidec’s base-plate manufacturing unit including 18 permanent and temporary employees • Reduced overall quality cost by 50% by developing and monitoring continuous improvement programs, aiming to reduce the number of defects and improve levels of quality.• Active team player in improving cycle time (by 20%) in die casting machining process inspection cycle.• Develop quality improvement programs and collaboration with operation / marketing/ R&D / customer service and annual failure rate (AFR)• Evaluate and schedule appropriate training programs and seminars for QEs, supervisors and inspectors.• NPI quality team player.• Responsible for the enforcement of Company’s Quality Programs, implement, maintain quality standards for continuous quality improvement.• Lead, guide and drive quality activities to meet customer’s expectation. • Responsible for Conducting Product and Process Audits at In-House & at Supplier Sites• Recruit and train supervisors, and provide them with documented quality standards as guidelines for their day-to-day work.• Work with the product development team to establish quality standards when a new product is developed.• Work with suppliers to help formulate quality standards for the goods produced.• Ensures that incoming components and materials will comply with the manufacturer’s quality standards, minimizes the time and cost of inspection, and contributes to the quality of the finished product.• Correlate, investigate and resolve matters pertaining to quality issues. • Responsible for In-house Quality Performance and Monitoring at Incoming Inspection Stage.• Provide engineering support to trouble shoot and resolve technical problems.

Singapore

• Responsible for process improvements in the form of scrap/waste reduction• Involvement in documents such as SOPs Control Plans, FMEAs• Develop gages and/or work with Engineering in the development of gages and work with the calibration lab in gage requirements.• Recording, monitoring and evaluating SPC with the engineering group• Qualifying suppliers for new product or product changes• Monitor daily production efficiencies and provide improvement/solutions to productivity roadblocks, and continually improve downtime issues.• Work with suppliers to assure the supplier meets QA specifications; corrective actions are developed and implemented when deviations occur• Provide engineering support to trouble shoot and resolve technical problems.• Conducted First Article Inspection for High Precision parts using CMM, Customized Gauges, Fixtures and other precision Measuring Instrument. • Responsible for jig and fixture qualification.• Successfully completed GEOpack 2.4V CMM training course conducted by Mitutoyo .

Bachelor'S Degree, Mechanical Engineering, First Class

Activities and Societies: ASME - Associate member

Education record