Quality Control Assurance

Ishrat Altaf

***** ****** **. ***# ***, Fremont, CA 94538 ******.********@*****.***

(216) 835– 8145

Objective:

Obtain a challenging Quality Control Lead position in medical device manufacturing to contribute with my skills, talents and experience. Achieving company goals in producing quality products and ensuring products meet all quality, customer’s specifications, and compliance requirements. Education & Certification:

ISO-13485:2016, Medical Devices Certification, Sep. 2018 ISO-9001:2015, Non-Conformance & Corrective Actions Explained, Jan.2024 ISO-15189:2022, Medical Laboratories Quality Assurance & Competence, Dec.2023 Certificate – Quality Control, Jun. 2015 – Dec. 2015, University of Punjab, Lahore BA - Political Science & MA – Education, University of Punjab, Lahore Interpersonal & Technical Skills:

- Over 12 years of hands-on experience in QC - Quality Control and QA - Quality Assurance.

- Responsible for supporting the quality Assurance & Regulatory compliance affairs team by creating, Revising & maintaining Documentation related to IVDH submission.

- Responsible to work cross Functional with Manufacturing, Operations, and project management teams to address documents gape, revise documents submit ECOs, and maintain project timeline to meet regulatory compliance requirements.

- Able to train employes on required skills with released quality SOPs, WIs and Checklists.

- Capable of managing QC inspection priorities to meet production daily shipments.

- Capable of being flexible as required tasks change and maintain smooth QC workflow.

- Experienced in auditing production areas for ISO 13485 & ISO-9001 elements.

- Trained in cGMP Good Manufacturing Practices.

- Experienced in monitoring, inspecting, and paying attention to details.

- Experience with manufacturing environment, equipment, and safety procedures.

- Work well under pressure and ability to handle multiple tasks.

- Excellent written and verbal communication skills.

- Working Experience with Microscope & CMM for Maturing & determining QC parts.

- Working experience with fully understanding of QMS (Quality Management System)

- Working experience with Net Suite, Salesforce Oracle & Squint ERP software’s.

- Working experience to initial for trouble shooting, Root cause Analysis and assist for CAPA.

- Working experience for Electromechanically parts assemblies.

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WORK EXPERIENCE:

Senior Quality Inspector – Cytek Biosciences -Fremont, CA (Jan.2021-Jan-2024)

- Responsible for performing QC on Medical Device instrument to maintain the quality Control for all phases of QC like INCOMING QC (IQC), IN PROCESS QC (IPQC) & FINAL QC(FQC).

- Dealing with bad parts to put for MRB or RE-TURN TO VENDOR or process for NCMR.

- Coordinate with NPI for First ARICLE ITEM to approve & work on Drawing to determine with manufacturing parts.

- Responsible to manage Inventory count list with correct Items and quantities.

- Responsible to work out for trouble shooting with Production & NPI team.

- Responsible to perform FINAL QC for finished goods & approved with Green QC TAG before shipment.

- Review all NCMRs (Non-Conformance Material Report) with production and QC inspectors.

- Handle problems related to in-coming inspection and assigning them to suppliers through Quality Engineers.

- Participate in MRB meetings with Quality and Manufacturing Engineers for weekly dispositions.

- Submit work report to Quality Manager and other department heads before closing the shift. Lead QC Inspector - Western Digital - Fremont, CA (Jan. 2019 – Jan 2021)

- Responsible for maintaining high quality of Western Digital Devices by supporting QC Inspector for Final Quality.

- Responsible for making sure Quality Control steps has been completed on a QC Checklist from Silicon Probe Area to proceed wafer for different operations to the relevant set up of devices.

- Performed QC inspection to check out the accuracy of all parameters and reading for the required operations.

- Responsible for issuing QC Tags to move products to next operation for another department.

- Responsible for organizing daily In-coming and Final Quality Control tasks/assignments to meet shipment schedule.

- Help in creating QC priorities with Production team and Quality Control Manager.

- Review all NCMRs (Non-Conformance Material Report) with production and QC inspectors.

- Handle problems related to in-coming inspection and assigning them to suppliers through Quality Engineers.

- Participate in MRB meetings with Quality and Manufacturing Engineers for weekly dispositions.

- Submit work report to Quality Manager and other department heads before closing the shift. Quality Control Inspector –Thermer fisher CA (Jun. 2016 – Dec. 2018)

- Responsibilities included for visually examining all products and determining what is acceptable and what is not, per the Defect Classification Codes.

- Released acceptable products to inventory or rejects products that are defective.

- Inspected products through the manufacturing areas at the machines to ensure the quality and identify defects.

- Pushed a light table, which is used to visually inspect product, up or down aisles.

- Responsible to retrieve bag of product by lifting from a shipper box, places bag on light table to visually examine the product over the light.

- Depending on findings and the amount of accumulated product, replaces bag into box, removes it to inventory totes, or places it into a bin for further sorting.

- Sorted and discarded defective products.

- Ensured all documents findings attached on Daily Quality Status Report (DQSR).

- Maintained QC Documents at the machines, labels, and bar codes.

- Daily submitted QC log email of completing all QC activities to QC Supervisor. Cros functional Quality production Supervisor - Interloop international, Faisalabad. PK

(Sep. 2008 – May 2016)

- Inspect to maintain for the Quality Control for the 100% Customer Satisfaction & Strive for the Zero defect.

- Managed with all QC process Like IQC, IPQC & FQC step by step with Production move.

- Supervised & synchronized the production with scheduler for production mix & meeting daily production target.

- Reviewed production employees’ timecards and filled out production reports.

- Predicted troubles and delays for production schedules.

- Checked out final product is as per customer specifications or not.

- Coordinated with maintenance technician on repair and maintenance of various PCB machines, including Reflow Soldering and Screen Printing.

- Submitted shift production report to management on daily basis. Recovery Inspector - Askari Leasing (PVT), Ltd. Faisalabad, PK (April 2007 – July 2008)

- Inspected all repossessed vehicles and generated detailed quality reports.

- Coordinated maintenance and repairing activities of vehicles.

- Managed recovery matters of all leased, terminated and repossessed vehicles.

- Monthly installment collection.

- Managed customer dealing and telephone calling for new promotions. References available upon request.

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