Summary
Overview
Work History
Education
Skills
Certification
CORE COMPETENCIES
Timeline
Generic
Praharsha Piduru

Praharsha Piduru

Ayer,MA

Summary

Dynamic Quality Leader with 16+ years of experience in quality management systems, regulatory compliance, and operational excellence in the medical device industry. Proven expertise in leading large cross-functional teams, driving continuous process improvements, and ensuring adherence to global regulatory standards, including ISO 13485, 21 CFR 820, and MDR. Adept at implementing statistically-based quality control processes, establishing robust training programs, harmonizing global practices, and overseeing end-to-end factory operations to enhance product quality and operational efficiency. Extensive experience with Class III medical devices, strategic partnerships, and engaging with regulatory agencies to resolve quality crises and maintain compliance.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Director of Quality and Engineering

Philips
06.2022 - Current
  • Directed a global team of 120+ associates managing complaint handling, post-market surveillance and corrections/removals for SaMD products, improving issues detection and driving them into pre-market quality.
  • Implemented advanced PMS analytics using PowerBI and AWS Cloudwatch, enabling the identification of potential product issues three months earlier than previous methods.
  • Reduced investigation costs by 60%, saving $2M annually, by outsourcing investigations to third-party vendors and ensuring quality standards were maintained.
  • Developed standardized KPI frameworks that reduced process deviation by 25%, stabilizing operations after major procedural changes.
  • Supported and successfully navigated multiple FDA audits by preparing comprehensive compliance documentation and leading inspection readiness activities.
  • Represented the organization in interactions with regulatory agencies, managing high-stakes quality crises and ensuring alignment with compliance requirements.
  • Built strategic partnerships across cross-functional teams and external stakeholders to align quality goals with business objectives.
  • Managed budget allocations (AOP) for PMS projects, balancing resource requirements with cost constraints while maintaining project timelines.
  • Aligned Quality Management objectives with corporate goals, fostering a culture of excellence throughout the organization.

Sr. Global Engineering Manager

Abiomed (J&J)
11.2019 - 06.2022
  • Managed global post-market engineering teams, driving a reduction in failure investigation processing time by 85% through streamlined workflows and automation.
  • Designed and deployed standardized processes for PMS reporting across U.S., EU, and APAC regions, achieving 100% compliance with EUMDR requirements.
  • Implemented factory-wide quality initiatives to address emerging risks, ensuring end-to-end oversight from incoming inspection to final product release.
  • Leveraged machine learning tools to categorize failure investigations, reducing categorization errors by 40%.
  • Improved customer satisfaction metrics by 20% through enhanced root cause analysis and proactive issue resolution strategies.
  • Spearheaded quality system improvements, ensuring consistent Class III medical device compliance.
  • Communicated quality strategies and policies to senior staff through presentations and reports, ensuring alignment with divisional goals.

Sr. Quality Engineer/Team Lead – Manufacturing & Supplier Quality

Abiomed
10.2017 - 10.2019
  • Aligned risk management programs with ISO 13485:2016, achieving zero nonconformances in regulatory inspections over two years.
  • Increased manufacturing yields from 75% to 95% by implementing data-driven MRB improvements and cross-functional training programs.
  • Led global supplier quality initiatives, including SCAR and PPAP processes, reducing supplier-related defects by 50%.
  • Spearheaded a comprehensive process validation initiative, ensuring compliance across new production lines and improving throughput by 20%.
  • Designed and implemented environmental monitoring programs to reduce contamination risks and improve compliance.
  • Acted as lead engineer during FDA and notified body audits, resulting in no critical observations.
  • Monitored and reported global compliance performance, ensuring alignment with regional regulatory requirements.

Quality Engineer Roles

Bio-Rad Laboratories, Medtronic Plc, Triumph Aerospace Engines
01.2015 - 04.2017
  • Facilitated ISO 13485 certification audits, achieving certification in record time by developing robust quality systems.
  • Reduced manufacturing failure rates by 35% through targeted root cause analysis and corrective action implementation.
  • Streamlined validation processes, cutting average validation cycle times by 25% without compromising quality standards.
  • Contributed to Class III device development projects, ensuring compliance with design control requirements.
  • Led ERP system migration projects, reducing operational downtime by 40% and enhancing cross-functional data integration.
  • Analyzed data for quality-related crises, recommending actionable solutions to mitigate risks and improve processes.
  • Developed and delivered training programs to enhance employees'' understanding of quality management principles, tools, and techniques.
  • Implemented continuous improvement initiatives, resulting in significant cost savings and enhanced product performance.

Education

Master of Science - Engineering (Mechanical & Manufacturing Engineering)

Arizona State University
Tempe, AZ

Bachelor of Science - Engineering (Mechanical Engineering)

Punjab Technical University
India

Skills

  • Quality Tools: Minitab, SAS JMP, SPC Tools, 8D Analysis, Process Validation
  • Statistical & Analytical Tools: PowerBI, AWS Cloudwatch, Palantir
  • Operational excellence
  • Customer complaint resolution
  • Quality metrics development
  • Six sigma methodologies
  • Problem-solving abilities
  • Test method validation
  • Supplier quality management
  • Engineering leadership

Certification

  • Lean Six Sigma Black Belt (LSSBB)
  • ISO 13485:2016 Lead Auditor Certification
  • AAMI Process Validation
  • Root Cause Investigation & Technical Writing

CORE COMPETENCIES

  • Leadership & Talent Development: Building high-performing teams, fostering diversity, and driving strategic initiatives.
  • Quality Systems Expertise: ISO 13485, FDA QSR (21 CFR 820), CAPA, QMS, MDR Reporting, Risk Analysis.
  • Class III Device Expertise: Ensuring compliance and managing risks for high-risk medical devices.
  • Strategic Decision-Making: Budget management, regulatory compliance strategy, and global standard harmonization.
  • Continuous Improvement: Process validation (IQ/OQ/PQ), KPI development, Lean Six Sigma Black Belt.
  • Regulatory Engagement: Successful interaction with FDA, BSI, and other global regulatory bodies.
  • Strategic Partnerships: Collaboration with cross-functional teams, external stakeholders, and vendors.
  • Factory Quality Oversight: Incoming inspection, in-process controls, and final release processes.

Timeline

Director of Quality and Engineering

Philips
06.2022 - Current

Sr. Global Engineering Manager

Abiomed (J&J)
11.2019 - 06.2022

Sr. Quality Engineer/Team Lead – Manufacturing & Supplier Quality

Abiomed
10.2017 - 10.2019

Quality Engineer Roles

Bio-Rad Laboratories, Medtronic Plc, Triumph Aerospace Engines
01.2015 - 04.2017

Master of Science - Engineering (Mechanical & Manufacturing Engineering)

Arizona State University

Bachelor of Science - Engineering (Mechanical Engineering)

Punjab Technical University

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