Tapan Oka
Doylestown
Summary
Senior Quality professional with 23+ years of experience in Supplier Quality Management, Certified Quality Auditor and Six Sigma Green Belt continuous improvement facilitator. Experienced with supplier quality management, ensuring compliance and reliability in supply chains. Utilizes advanced problem-solving techniques to address quality issues and enhance supplier performance. Strong understanding of quality control methodologies and effective communication with cross-functional teams. Demonstrated track record in implementation successful Quality initiatives at Danaher, Neuronetics, Draeger, and Siemens
Overview
22
22
years of professional experience
Work History
Staff Supplier Quality Engineer
Siemens
01.2022 - Current
- Support ISO13485 audits. SME for supplier management. Perform supplier audits per FDA820/ISO13485 and Siemens internal requirements.
- Manage SCAR (Supplier Corrective Action) database.
- Manage yearly supplier evaluation process and reports.
- Manage Flanders Product hold process worldwide.
- Implemented part specific inspection plan(s) to reduce internal/external(vendor) inspection time and cost by more than 40%.
Senior Supplier Quality Engineer
Draeger
04.2016 - 12.2021
- Support ISO/ATEX/NIOSH/ABS/ FDA audits for two US facilities.
- Participate in Global supplier consolidation efforts with teams in Germany, China and Japan.
- Responsible for Supplier approval, setup, inspection planning in SAP.
- Conduct Supplier quality audits per ISO9001, ISO13485, or FDA 820
- Implemented supplier improvement module in SAP.
Senior Supplier Quality Engineer
Siemens
06.2014 - 04.2016
- Conduct Supplier quality audits per ISO13485/FDA 820/ Siemens internal requirements, qualify new suppliers.
- Conduct monthly site meeting to review supplier KPI’s
- Work with engineering, product management to ensure requirements are adequately addressed with supplier.
Senior Quality Assurance Engineer (New Product Development – Class II)
Neuronetics, Inc
12.2012 - 06.2014
- Analyze post market surveillance data and identify product trends
- Provide Quality Engineering support for; design controls, risk management, verification, validation(Beta)
- Review/approve new product documentation ensuring compliance to ISO and FDA regulations.
- Lead software/hardware DFMEA and update Risk Management file.
- Conduct/Support in-house, onsite contract manufacture, and 3rd party audits.
- Streamlined Complaint Management System. Achieved 50% reduction in closure time.
Quality Engineer II (New Product development – Class I and II Device)
Danaher-Imaging Sciences International
03.2011 - 12.2012
- Ensure consistency, completeness, and adherence to FDA regulations and SOP’s while implementing manufacturing and quality documentation for Design Transfer activities
- Review/Approve new product documentation. (Trace Matrix, Market/functional/Software requirements)
- Review/Approve IQ/OQ/PQ for manufacturing fixtures, machines, and software.
- Manage initiation and drive closure of CAPA’s, deviations, and OOB investigations as assigned.
- Conduct on site supplier quality audits per ISO9001:2000, ISO 13485 standard.
Quality Engineer (Class I and II Device)
Danaher-Kavo/Gendex Dental Systems
08.2005 - 03.2011
- Implemented Production Part Approval Process (PPAP) tailored to Medical Device Industry
- Responsible for Internal/External PPM, Customer complaints.
- Responsible for monthly Quality improvements/updates to sales department and tech support department.
- Monitor monthly internal / supplier rejection rate and provide reports to upper management.
- Conduct weekly quality review meetings with WSL’s.
- Work with design engineering to correct drawing inadequacies and communicated to suppliers on as required basis.
- Reduced 80% supplier PPM/NCR through Corrective and Preventive measures.
- Implemented 8D corrective action process at suppliers.
- Worked with teams in Japan and Europe to solve/update product issues.
- Performed Kaizen activities such as 5S, Standard work
Quality Engineer Manager
Morse Automotive Corp (Caliper Division)
08.2003 - 08.2005
- Oversight of the ISO/QS Quality systems.
- Monitor all elements of Quality Manual and Quality procedure to keep the system current
- Lead internal auditor for ISO 9001-2000 and QS 9000 facilities.
- Experience in writing work instructions, procedures etc. performed gage R&R.
- Designed and implemented process audit documentation
Education
Six Sigma Green Belt -
Villanova University
01.2012
MS, Master’s Manufacturing Systems - undefined
SIU
Carbondale, IL01.2002
BS, Production Engineering - undefined
K.B.P College of Engineering
Satara, MH, India01.1997
Skills
- Supplier Quality Engineering
- Audits (ISO/FDA)
- Validation (IQ/OQ/PQ) , PPAP
- Corrective and Preventive Actions (CAPA)
- Continuous improvement
- KPIs, Dashboards, and Metric Management
- Root Cause and Trend Analysis
- Process Flow Mapping
Accomplishments
- Standardize E2E (End to End) Global Supplier Quality metric based on point system
- Setup N95-Mask Supplier base for Draeger US – Mask Facility
- Standardize Global PPM / Supplier evaluation module in SAP for Draeger Medical
Timeline
Staff Supplier Quality Engineer
Siemens
01.2022 - Current
Senior Supplier Quality Engineer
Draeger
04.2016 - 12.2021
Senior Supplier Quality Engineer
Siemens
06.2014 - 04.2016
Senior Quality Assurance Engineer (New Product Development – Class II)
Neuronetics, Inc
12.2012 - 06.2014
Quality Engineer II (New Product development – Class I and II Device)
Danaher-Imaging Sciences International
03.2011 - 12.2012
Quality Engineer (Class I and II Device)
Danaher-Kavo/Gendex Dental Systems
08.2005 - 03.2011
Quality Engineer Manager
Morse Automotive Corp (Caliper Division)
08.2003 - 08.2005
MS, Master’s Manufacturing Systems - undefined
SIU
BS, Production Engineering - undefined
K.B.P College of Engineering
Six Sigma Green Belt -
Villanova University
CORE COMPETENCIES
- Supplier Quality Engineering
- Validation (IQ/OQ/PQ) , PPAP
- Continuous improvement
- KPIs, Dashboards, and Metric Management
- Audits (ISO/FDA)
- Corrective and Preventive Actions (CAPA)
- Root Cause and Trend Analysis
- Process Flow Mapping