Quality Analyst/Document Controller / Asst. Quality Manager
SMC Ltd
Total years of experience :12 years, 7 Months
Document control:-
Main lead of document control through proper traceability and track down information.
Controlling of Documents such as Maintaining in soft and hard copy with stamp of Master control & Obsolete copies.
Distributing the control copies of latest revision to relevant department according to distribution matrix.
Administers record, distribution, filing and archiving of all incoming and outgoing deliverables.
Assists Engineering team in the implementation of Document Control procedure.
Maintaining (DHR) Device history records and Product releases for each lot.
Assistant Quality Manager:
Monitoring quality requirements in accordance with the company quality assurance policies and customer specifications.
Training contract / temporary employees in the Incoming inspection procedures, GMP (Good manufacturing practices), GDP (Good Documentation Practices), sanitation awareness, 5’s, 7 QC tools, FDA (Food and drug administration) awareness.
Conducting inspections at in-process, in-coming and completes the final inspections.
Accountable for performing accurate visual inspection of raw materials in accordance of COC (certificate of compliance), components, and sub-assemblies as per Inspection Plans and Specification Requirements.
Maintaining inspection equipment and performing material kit audits to insure accuracy and integrity of the kitting process.
Working with other company personnel to resolve inspection questions. Communicate with project engineers to ensure schematics are in compliance with the final product.
Responsible for ISO 9001:2008 & ISO 13485:2003 certification.
Conducting various tests and quality checks on finished products. ensure that all products have been tested and fall within standards, measured to specifications and within tolerances, readability of labels, etc.
Responsible for training on the procedures and Hygiene practices to the organization.
Maintaining Microbial record in ISO Class 7 and Class 8 as per procedure.
Creating Master documents to track Calibration and latest version of Documents and records.
Handled team of 6 to 8 people.
Prepared control plan, FMEA, Risk management documents.
Preparation of Dashboards and operational metrics trends.
Organizing Weekly review meeting and Management review.
Responsible of reporting 8D and Supplier CAPA.
Responsible for the new product development.
Responsible for vendor evaluation, selection Approval.
Managing customer requirement as per the procedure and norms.
Awareness on the Clean room class limits according ISO Standard 14644 also on ISO 14698 Clean rooms and associated controlled environments - Bio contamination Control
Chairperson for safety committee and arranging for proper PPE items.
Highlights
Headed audit ISO 13485:2003 and ISO 9001:2008 successfully for the organization and Implemented.
Participated in Validation activity as per GHTF (Global health task force) standard.
Prepared Validation protocol along with completion reports for assemblies and plastic molded parts.
Performed Minitab 16 for capability studies, Gauge R and R, Normality test, Probability plot, DOE, , Run charts.
Responsibilities
Incoming Inspection & entries accepted through SAP (QA) module.
Ensuring conformance to shippers or packaging sheet of all parts returned from customer or special performance by subcontractor.
Supervising transfer of discrepant material to quality control per aside for this purpose.
Inspecting sub-assemblies in accordance of print.
Inspecting sub-assemblies in accordance of print and any dimensional requirement.
Responsible for incoming Quality.
Responsible for Process inspection & Final Inspection.
Process inspection include- Soldering of PCB, Pad printing, Special test of torque to switches, etc..
Prepared inspection records and tracking of the defects per PPM level.
Satisfied customer for < 500PPM (Zero defects) and always meet the customer requirements.
Managed the project of 260 types of different Pushbutton.
Worked on lean line & implement Kanban system
Responsibilities
Responsible for Final & Process Quality.
Voltmeter sub assembly inspection for the coil and pointer.
Tracking the testing records and cosmetic inspection.
Flexibility of working in production and quality department.
