Balwinder Singh Hayer

Osprey Street, Lake Forest, CA 92630 •949-***-****

adiyu4@r.postjobfree.com • PortFolio: https://balhayer.github.io Experience Highlights:

B. Braun Medical USA Inc. - Irvine, CA present

Sterilization Assurance (Engineering)

• Perform validation of Sterilizer Load Report (SLR) based on temperature mapping and validates the data in EBR before QAPR.

• Responsible for the resolution of Deviations (DN's), NCR, ERF, PPDR using root cause analysis during deviation investigation process.

• Investigate Root Cause Analysis for Sterilizer batches issues during Process i.e. OOS, Valve Mismatch, Manual Release, Batch Failure.

• Provides input and quality oversight over investigations, which includes review and approve the investigation reports.

• Monitors manufacturing process verifications to ensure compliance with operating procedures and specifications V&V 21 CFR P10.

• Monitors Sterilizer operations and verification of specifications to release product to QA Product Release to the market.

• Conducts investigation for OOS specification and verifies with Wonderware Historian using manual release analysis.

• Conducts timely Quality review of associated data in SLR reports, including data utilized using PLC system to support batch release. Medtronic Inc. - Irvine, CA Feb 2016 – Aug 2018

Quality Assurance Analyst

• Experience working with medical devices including micro-catheters and stents, performing Quality assurance specifications, equipment calibration, quality control and conduct non-conformance review on final products.

• Prepared and executed Process Validation Protocols including developmental studies such as Water batches Process Justification.

• Provided assistance for equipment and process validation activities, including authoring of validation protocols for sterilization and annealing of batches of Micro-catheters, stents, guidewires and other medical products in-line.

• Initiate non-conformance reports (NCR’s) based on the discrepancies evaluated in the process or product.

• Ensure complete investigation and verification of the non-conformance reports and ensure impact on product and disposition of the product before product release.

• Executed critical test protocol and non-critical test protocol including empty and loaded chamber by temperature mapping using thermocouples, data loggers, and perform test in Heat Set for Stents for all sizes.

• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

Ramsons Neurovascular - Chandigarh 2014 - 2016

Associate Validation Engineer

• Develop and Write validation Installation/Operation Qualifications (IO/OQ) for equipment used in manufacturing of medical devices.

• Validated a manual Wax injection press to produce over 10 different class III medical devices with different geometrics.

• Create Standard Operation Procedures (SOP) for Setup, Operation, and Preventive maintenance of production equipment's.

• Optimize Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

• Verified site sterilization procedures for 20,000L Bioreactors and other critical process equipment.

• Execute Process Qualification and Re-Qualification, analyze data, write Qualification Final Reports generated by PLC, EBR system.

• Develop Test Plan, Test Cases, Test Result Reports for Manual as well Automated Testing for validating production equipment’s.

• Performed Design of Experiment (DOE) and Statistical Process Control Studies (SPC) as a part of the process development, improvement, simulation to get a product of desired specifications. Education:

CALIFORNIA STATE UNIVERSITY, FULLERTON, CA

Bachelor of Science in Engineering in Computer Science IRVINE VALLEY COLLEGE, IRVINE, CA

Associate Degree of Arts & Emphasis of Liberal Studies SIX SIGMA YELLOW BELT SPECILIZATION CERTIFICATION BY COURSERA University System of Georgia

Expertise:

•

•

•

•

•

•

Medical Device Design Engineering

Clean-room Manufacturing & Engineering

Injection Molding & Extrusion Manufacturing

External Quality ISO-9001 Standards

Six Sigma Green Belt/Root Cause Analysis

5 Ways, Pareto Charts, Ishikawa Diagram

•

•

•

•

•

•

Validation Master Plan (VMP)

Risk Management Tools Analysis

Non-Conformance Report Analysis (NCR)

SDLC Complete Software Cycle Knowledge

Gaging Measurement System Analysis

IQ, OQ, PQ Protocols, ALCOA, 21 CFR 11

Software: HTML5, JavaScript, Java, SQL, CSS3, C++, UFT, Selenium, MS Office, AutoCAD, Track Wise (SOP drafting), QAD, Wonderware, SAP Scada Softwares, System Validation, Excel Spreadsheets Validation, EBR Validation, Change Control Documents Validation

Contact this candidate