JAYASANGAR MUTHU
Sr Quality Engineer
BUKIT MERTAJAM,PENANG
Summary
Thorough Quality Engineer adept at performing quality inspections and identifying root causes for non-conforming material issues. Hardworking and meticulous with a passion for continuous improvement.
Driven Quality Engineer with great knowledge of process change documentation and root cause analysis. Dedicated to best-in-class work.
Overview
15
15
years of professional experience
4
4
years of post-secondary education
Work History
Senior QA Engineer
KW PRECISION (M) SND BHD
PRAI PENANG
04.2018 - Current
- 1.Lead, facilitate and participate in the Corrective Action process (8D) investigations, the MRB (Material Review Board) process, the First Article process, Part Certification process, and the Quality System auditing process.
- 2.Enforce implementation of ISO9001:2015, ISO13485:2016 & ISO14001 Quality Procedures at all departments and perform periodical Quality Audits and make recommendations for continuous improvements.
- 3.To response for customer complaint and CAPA request (8D Report & related datasheet)
- 4.Ensure all measuring equipment’s and devices are calibrated periodically and records are maintained.
- 5.Ensure that all production critical supplier issues are resolved in a timely manner, and corrective actions are implemented correctly.
- 6.Ensuring ongoing site supplier evaluation is performed. This would be achieved by using site information collected from Receiving Inspection, MRB, Customer Returns, SCAR database and by liaison efforts with customer work cells. Performance will be reported internally and to the supplier.
- 7.Continuously lead and review the compliance of the internal functions with the established QA plan, guidelines, and processes.
- 8.Maintain the Quality Manual and Quality procedures and ensure contents are appropriate for business. Analyse current and future procedural needs of the business
- 9.Coordinate the review of quality procedures associated with plant continuous improvement initiatives.
- 10.Maintain the Standard Operating Procedure content and coordinate the issuing of these documents.
- 11.Maintain the internal audit records, vendor and customer audit files.
- 12.Monitoring and lead the implementation of internal audits.
- 13.Perform other duties and assignment as instructed by QA Manager from time to time
Senior QA Engineer
PARAMIT (M) SND BHD
SIMPANG AMPAT PENANG
09.2011 - 01.2018
- 1.Be a Product owner to develop and implement process / product improvement strategies, assist in Yield improvement, Preventative maintenance and troubleshooting activities.
- 2.Review and analyses related documents, specifications, datasheets (Drawings) and preparation of various engineering deliverables such as Process Flow diagrams, Work Instruction or SICs.
- 3.Perform internal audit for ISO 9001:2000, ISO 13485 and ISO 14000
- 4.Prepare documentation such as IQ, OQ and PQ for new medical products.
- 5.Responsible for the inspection and testing of manufacturing processes and products to ensure the product quality
- 6.To liaise with customer & internal team for the related quality issues
- 7.To response for customer complaint and CAPA request (8D Report & related datasheets)
- 8.Conduct necessary quality inspections using proper equipment and techniques
- 9.Assist with training and instruction for the QA/QC & leaders at all new products & QA measuring procedures
- 10.Provide management with detailed quality reports as required – daily, weekly, monthly
- 11.Responsible and co-ordinate in all calibration of test and measuring equipment.
- 12.Follow-up on the quality feedbacks & monitoring an effectiveness of countermeasure replies
- 13.Overall monitoring on the quality performances of the product & process
QA Assistant Engineer
Thermo Fisher Scientific Singapore
ANG MOH KIO
08.2007 - 03.2011
- 1.To monitor and ensure the product quality is complying to specification and product quality standards;
- 2.Manage quality control inspectors and ensure the inspection activities delivered on time;
- 3.Initiate continual improvement activities based on external (customer and supplier) and internal feedbacks;
- 4.Responsible for quality assurance activities and documentation to meet ISO & regulatory requirements;
- 5.Work with cross functional team during evaluation to ensure the compliance of products, and prepare the evaluation reports and improvement actions for closure;
- 6.Participate in pre-customer drawings and technical requirements review, and establish/define Inspection & Testing criteria for the products/processes;
- 7.Evaluate customer quality standards, tolerances, measurement benchmarks, and measurement fixture requirements;
- 8.To prepare the acceptance/reject/limit samples for production references;
- 9.Handle customer complaints and ensure complaints are well addressed;
- 10.Document root cause, containment action, permanent corrective action and preventive action in the CAPA report;
- 11.Monitor and ensure the effectiveness of the ECN, and prepare PPAP documents (including: PFMEA, Control plan, SCR, etc);
- 12.To perform ad-hoc tasks assigned by superior.
Education
Degree in Mechanical Engineering -
Edmonton University
Kuala Lumpur 03.2011 - 12.2014
Skills
Root cause analysis
undefinedTimeline
Senior QA Engineer
KW PRECISION (M) SND BHD
04.2018 - Current
Senior QA Engineer
PARAMIT (M) SND BHD
09.2011 - 01.2018
Degree in Mechanical Engineering -
Edmonton University
03.2011 - 12.2014
QA Assistant Engineer
Thermo Fisher Scientific Singapore
08.2007 - 03.2011
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