Quality Engineer Engineering

Parthi Reddy

Email: **********@*****.***

Phone: 732-***-****

Summary:

Engineering professional in the Medical device manufacturing responsible for providing engineering support to Manufacturing Operations and Continuation Engineering by resolving quality related issues, improving product quality, investigating customer complaints and reducing costs. Utilized the Correction and Preventive Action system to pursue continuous improvement of the Quality System and products. Assisted with supplier support and played an active role in cost reduction projects that supported Lean initiatives. Represented Quality Assurance on Research and Development project teams and supported Manufacturing Engineering to complete validations and conducted validations as it relates to quality of products. Communicated with cross functional teams at various levels in the organizations such as R&D, Regulatory, Manufacturing and Post Marketing Surveillance to achieve project goals.

Technical Skills:

ISO 9001/ISO 13485 (Quality Management Systems)/ISO 14971 (Risk Management for Devices)/21 CFR Part 820 (FDA Devices, US/Quality System Regulation (QSR)/Corrective Action and Preventive Action (CAPA)/Advanced Statistical Root Cause Analysis/Risk Analysis/Failure Mode Effective Analysis (FMEA: Design DFMEA & Process PFMEA)/Nonconformance Management (NCM)/Design of Experiments (DOE)/Change Control/GAP Analysis/Design Control/Design History File (DHF)/Validation Test Plans (IQ, OQ, PQ)/Process validation and Capability Studies/Test Method Validation (TMV)/Gage R&R/Process Control Plan/Quality System Management/Complaint Handling/Reliability Analysis/New Product Development (NPD)/Design Verification/Supplier Qualification/Incoming Quality Computation & Simulation – MATLAB/Six Sigma/Lean Manufacturing/Statistical Analysis – Minitab.

Professional Experience:

Viant Medical, Wilmington, MA Jan 2018 – Present

Sr.Quality Engineer

Designed and specified inspection and testing procedures/systems to ensure products conform to specifications and quality standards.

Investigated/analyzed in-house and field failures (returns) and monitored quality trends. Proposed and implemented possible solutions/improvements utilizing the Client Corrective and Preventive Action (CAPA) system.

Initiated, reviewed, and approved disposition for Nonconforming Product and supported Material Review Board (MRB) teams.

Initiated supplier corrective actions and assisted Purchasing to continuously improve supplier quality and enhanced supplier relationships.

Initiated, reviewed, and approved Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.

Lead efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance.

Responsible for first article inspection, incoming and in process inspections and lot release testing, including sampling strategies and test methods

Evaluated product and process performance such as, pareto charts, statistical process controls, and process maps.

Developed and approved quality system documentation such as operations procedures and work instructions.

Worked with Manufacturing Engineers in developing process validation protocols, FMEAs, quality plans, manufacturing procedures, inspection plans, and specifications.

Provided engineering support to manufacturing operation and address quality issues arising on the production floor.

Worked with cross-functional teams to resolve high risk production issues and documented recommended corrective actions using the quality systems procedures (NCMR & CAPA).

Improved manufacturing methods, optimized product performance and reduce manufacturing costs through Lean 6 Sigma methodology.

Defined and generated all required documentation in support of manufacturing protocols, reports, changes and manufacturing instructions including Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders and statistical analysis.

Supported and performed Quality Audits - Internal, External, FDA, BSI Regulatory Bodies

Developed Statistical inspection sampling plans

Performed Product Impact Assessments: Analyzed and rationalized CAPAs, Nonconformance (NCs) & Observations, Failure Investigations and root cause analysis

Developed and/or reviewed Process Qualifications, Test Method Validations, Gage R&Rs, Process Capability studies, Design of Experiment (DOE), production control plan. Review, Marketing and Product Spec Reviews, Regulatory compliance, Packaging and Sterilization.

Supported First Article Inspections, In-Process Inspections, Sampling Plans, product/components testing, inspection and acceptance criteria.

Acclarent, Irvine, CA Jul 2015 – Dec 2017

Quality Engineer

Utilized quality engineering and lean tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits and to assist in specification development.

Investigated instances of nonconformance and facilitates the determination of root cause and corrective action/preventive action including the effectiveness of these actions.

Analyzed routine and test data for improvement opportunities.

Provided statistical support for sampling plan and analysis, DOEs, Paretos, ANOVA, and SPC applications.

Supported validations to assure all processes comply with company specifications to include internal quality systems and ISO requirements as well as applicable regulations.

Reviewed and approved all associated documentation including risk management files and quality records.

Developed quality plans, inspection procedures and control plans for new product development and delivery.

Developed and maintained Control Plan and PFMEA documentation and procedures.

Led, created, and updated DFMEAs for new implants & instruments.

Ensured documentation is aligned with corporate standards which includes FMEA, DFMEA, Manufacturing Process Characterization / PFMEA, product life cycles, Gage R&Rs.

Performed gap analysis of Design Control Quality System, determined changes required to close gaps, and implement changes.

Wrote, reviewed, & approved design verification & validation protocols (DOEs, IQ/OQ, PQ).

Responsible for investigations and implements robust corrective/preventive actions for process/device non-conformances; monitor complaint rates and initiates improvements where required; contribute to Material Review Board; support improvement initiatives.

Education:

Master of Science (MS) in Mechanical Engineering Mechanical Design

California State University Northridge (CSUN), Northridge, CA

B.Tech in Aeronautical Engineering.

Bhagwant University, Rajasthan.

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