Hyderabad, Telangana, India
I have total 9 yrs of experience in quality dept/NPD. In the field of DFM, DFI, In process quality, SQA, Product development,Manufacturing,Risk Management, FMEA, V&V, MSA, Process Capability,NPI, REACH, RoHS,21CFr 820,ISO 13485, Welding(GTAW/LBW/EBW etc)
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Job Title: Senior Advance operation Engineer (New Product Introduction) I was working in the operation function of JR business group and responsible for the advance operation deliverables and worked on different design transfer project that included Triathlon project having scope of design transfer of different instruments for the knee joint implant and Triglobe project for Hip joint implant. Key Responsibilities and Characteristics: 1. Worked with product development team for the identification of features attribute that are critical for the design function. 2. Analyzed the feasibilities of the critical features attribute requirement with the manufacturing site and working with product development team on the inputs provided by the manufacturer. 3. Reviewed equipment qualification and special process validation protocols-IQ/OQ/PQ and reports performed by the manufacturing site as per quality standard requirement. 4. Reviewed GRR (Gage R&R) reports performed by the manufacturing site as per quality standard requirement. 5. Reviewed process capability reports performed by the manufacturing site as per quality standard requirement. Selected Accomplishments: 1. This was my first assignment with healthcare industry environment and learnt the industry standard and requirement in the short span of time was the accomplishment and it was appreciated by the project manager 2. Successfully completed project deliverables on time with high quality
-Responsible for Monitoring,Receiving, In process, final quality of product., -Responsible for Spc,Msa,layout inspection,QAV audit. -Documentation of Records as ISO/TS 16949,ISO 9001. -Responsible for daily and monthly Quality MIS. -Done Process Validation and freeze the process at supplier end.
1.Responsible for preparation of all qa dept. according to TS 16949:2009. 2.Done MSA, SPC, according to the plan. 3.Cross check raw material with Indian and international stands such as IS 513, IS 3074, IS 5429, ASTM A500, DIN 2393/1994, JIS Sus 409L. 4. Using 7qc tools for problem solving. 5. Prepare SOP/ WI for shop floor. 6. Done QAV in house and supplier end. 7. Done poke yoke for fool proofing. 8. Prepare and maintain PPAP doc.(like PDF, PQCS, pfmea, checking aids etc.). 9. Handling customer complaints and send action plan for issue arises. 10.Prepare and send monthly MIS. 11. Done internal audit, product audit, process audit.