Quality Engineer Risk Management

Pallavi Bharadwaj

Quality Engineer – Medical Devices

Email: ******************@*****.*** Ph: +1(908) 666 – 0324

Professional Summary

Around 9+ years of experience as a Quality Engineer in the medical device industry, specializing in FDA regulations, ISO standards (ISO 13485, ISO 14971), and 21 CFR Part 820 compliance.

Expertise in executing IQ, OQ, PQ validations, CAPA management, and FMEA methodologies, ensuring risk identification, resolution of nonconformances, and process improvements.

Skilled in Risk Management, utilizing tools like FMEA and Six Sigma to drive continuous quality improvement and mitigate potential product and process risks.

Quality Engineer with expertise in FDA regulations (21 CFR 820, 21 CFR Part 11), ISO 13485, ISO 14971, EU MDR, and Risk Management in the medical device industry.

Hands-on experience in IQ, OQ, PQ validation, CAPA management, 8D problem-solving, and FMEA methodologies to improve product quality and compliance.

Strong knowledge of Design Controls, Change Management, and Quality Management Systems (QMS) to support regulatory submissions and audits.

Proficient in Root Cause Analysis (RCA), Process Improvement, Lean Manufacturing, Six Sigma (DMAIC), and Statistical Process Control (SPC) for defect reduction and efficiency enhancement.

Skilled in using Power BI, Minitab, JMP, Windchill PLM, SAP QM, MES, LIMS, AutoCAD, and SolidWorks for data analysis and quality improvement.

Experienced in supplier quality management, vendor audits, and risk-based decision-making to ensure compliance with industry standards.

Proven ability to lead internal and external audits (ISO, FDA, Notified Body) and post-market surveillance to maintain regulatory readiness.

Strong proficiency in Quality Management Systems (QMS), Medical Device Reporting (MDR), and Design Controls, ensuring compliance with global regulatory standards, including FDA and ISO.

Hands-on experience with AutoCAD, SolidWorks, and statistical tools (SPC, DOE), supporting product design, process improvement, and operational efficiency.

Certified Six Sigma Green Belt with a proven track record of leading cross-functional teams, conducting audits, and ensuring quality throughout the product lifecycle.

Managed Project Quality, Risk Management, and ensured compliance across regulated environments, including FDA/EMA-regulated systems and processes.

Experience in performing root cause analysis, developing and implementing CAPAs, as well as participating in validation processes and reviews for various equipment and processes.

Demonstrated ability to work both independently and as part of cross-functional teams, enhancing communication, analytical, and management skills across regulated environments.

Proven track record of achieving success in quality and compliance projects, contributing to continuous improvement in the life sciences industry, focusing on maintaining high regulatory standards.

Extensive knowledge in Risk Management and Risk Mitigation Strategies for life sciences projects, ensuring adherence to regulatory requirements and maintaining a validated state for processes and systems.

Played a critical role in process optimization by implementing lean methodologies and Six Sigma principles to enhance operational efficiency in manufacturing and quality control environments.

Proficient in Change Management processes, managing changes in systems and processes with thorough impact assessments and implementation of change control mechanisms.

Collaborated closely with cross-functional teams, including R&D, manufacturing, and regulatory departments, to ensure alignment of project goals with regulatory requirements and business objectives.

Experience in Vendor Management, ensuring that external partners and suppliers comply with industry standards and project requirements, contributing to successful project execution and product quality.

Technical Skills

21CFR 820 (QSR) & ISO 9001, 21 CFR Part 11, Windchill, PLM, change control, Design Controls, FMEA, PRM, PFMEA DMF, DHF, DCAF and CAPA, Risk Management, Standard operating procedures (SOP), IQ, OQ, PQ, TMV, CAPA, FMEA, PPAP, APQP, DHF, DMR, MSA, RCCA, Kaizen, 8D Problem Solving, Change Control, CREO, Minitab 16, Technical writing (plans, protocols, and reports), Batch record review and release of raw materials, components, and finished goods, ISO 13485, ISO 14971, EU MDR, IEC 60601, GMP, GDP, Risk Management, QRQC, RCCA, Problem Prevention Systems (PPS), 5 Why Analysis, Fishbone/Ishikawa Diagrams, post-market surveillance, real-time quality metrics tracking, Process Capability Analysis (Cp, Cpk, Pp, Ppk), Measurement System Analysis (MSA), and Statistical Tolerance Analysis, automating nonconformance tracking, CAPA workflows, and audit readiness dashboards.

Professional Experience

Sr. Quality Engineer, Abbott Laboratories, Green Oaks, Illinois Dec 2023 – Present

Lead the verification and validation activities (IQ, OQ, PQ, TMV) for advanced medical devices, leveraging statistical process control (SPC) methodologies to optimize product quality and manufacturing processes.

Formulate and execute Test Method Validation protocols to ensure the reliability and compliance of testing procedures with regulatory standards.

Conduct thorough assessments of Device History Records (DHR) and Incoming Inspection documentation to verify completeness and adherence to specifications.

Implement PFMEA techniques to identify potential risks in the manufacturing process, driving initiatives that enhance product quality and safety.

Designed a real-time quality monitoring dashboard in Power BI, reducing audit preparation time.

Led a Nonconformance Reduction Initiative, improving First Pass Yield (FPY) in the production line.

Implemented automated DHR review processes, improving compliance tracking and documentation accuracy.

Optimized incoming inspection sampling plans, reducing material rejection rates.

Collaborate cross-functionally to establish risk management strategies, effectively reducing defect rates and improving overall manufacturing efficiency.

Utilize root cause analysis methodologies to investigate production issues, achieving significant reductions in nonconformances through targeted corrective actions.

Oversee compliance with Good Manufacturing Practices (GMP), ensuring meticulous management of validation documentation, including protocols, reports, and Standard Operating Procedures (SOPs).

Engage with the Quality team to address customer complaints, spearheading investigations and implementing corrective actions to prevent recurrence.

Contribute to Design Control efforts, utilizing expertise in validation processes to facilitate the development of innovative medical devices.

Coordinate and conduct internal audits to confirm compliance with quality systems and regulatory standards, strengthening overall quality assurance efforts.

Senior Quality Engineer, Johnson & Johnson, New Brunswick, NJ Oct 2021 – Nov 2023

Oversaw the development and maintenance of the quality management system (QMS) in alignment with ISO 13485 and FDA regulations, ensuring thorough documentation and process adherence.

Analysed customer complaint trends and performed risk assessments for a portfolio of Neurovascular products, providing critical insights for management review meetings.

Developed customized CAPA tracking tools, improving response time for high-risk quality issues.

Played a key role in process validation strategy development, ensuring new product introduction (NPI) met FDA submission requirements.

Led a supplier risk mitigation program, resulting in fewer deviations in incoming components.

Collaborated with regulatory teams to enhance design history files (DHF) and risk management documentation.

Conducted comprehensive investigations into non-conformances, employing methods such as FMEA to document findings and implement corrective actions.

Actively participated in the design and development of new products, ensuring rigorous quality management practices from initial design through market launch.

Developed and maintained documentation for quality systems, including Design History Files (DHF) and Device Master Records (DMR), to ensure compliance and traceability.

Collaborated with risk management teams to formulate strategies addressing FDA observations, preventing potential regulatory escalation.

Championed continuous improvement initiatives, utilizing project management and DMAIC methodologies to deliver on key performance indicators.

Automated post-market surveillance processes through the development of dashboards, enhancing the ability to monitor product performance and safety.

Managed CAPA processes, ensuring effective tracking and resolution of quality issues across product lines.

Drove the implementation of process capability assessments, identifying operational improvement opportunities through statistical analysis.

Quality Engineer, Teleflex, Wayne, Pennsylvania Jul 2019 – Sep 2021

Executed validation protocols and quality assessments, ensuring compliance with internal and regulatory standards governing medical devices.

Worked collaboratively with interdisciplinary teams to refine product validation processes, focusing on risk assessment and quality enhancement initiatives.

Investigated nonconformities in product quality, leading CAPA initiatives that significantly improved product reliability.

Established a Supplier Quality Scorecard, enabling data-driven decisions for vendor selection and performance improvement.

Introduced a Process Capability Study framework, optimizing machine qualification and reducing variation.

Conducted first-time implementation of SPC techniques on the shop floor, improving process stability.

Developed and maintained critical documentation, including PFMEA and risk management files, to support regulatory compliance and quality assurance activities.

Conducted internal audits to evaluate compliance with industry standards, contributing to the continual enhancement of quality systems.

Championed continuous improvement initiatives aimed at process optimization and waste reduction, promoting a culture of quality excellence.

Coordinated with suppliers to ensure that incoming materials met established quality standards, reinforcing the integrity of the production process.

Utilized statistical tools for data analysis to identify trends and inform operational enhancements.

Designed and facilitated training programs on quality systems and compliance requirements, fostering a knowledgeable workforce.

Collaborated across teams to resolve quality issues, ensuring alignment with organizational quality objectives.

Supplier Quality Engineer, Stryker Corporation, Kalamazoo, Michigan Mar 2017 – May 2019

Led supplier quality engineering efforts, ensuring compliance with FDA regulations and ISO standards through extensive audits and process evaluations.

Developed product assurance plans utilizing statistical sampling to verify that materials met quality specifications prior to manufacturing.

Strengthened First Article Inspection (FAI) and PPAP documentation, aligning with stricter regulatory requirements.

Conducted Gage R&R studies on supplier components, reducing measurement uncertainty and improving acceptance rates.

Created a structured supplier training program, increasing supplier compliance with quality expectations.

Executed First Article Inspections (FAI) and contributed to Advanced Product Quality Planning (APQP) for new product introductions, maintaining quality oversight throughout development.

Coordinated with suppliers to ensure compliance with regulatory requirements for product submissions, enhancing quality across the supply chain.

Analysed supplier performance metrics to identify trends and drive initiatives that improved overall quality and efficiency.

Managed the execution of process validation protocols (IQ/OQ/PQ), collaborating with cross-functional teams to optimize product quality and safety.

Stayed current on industry regulations, leveraging knowledge to guide supplier quality strategies.

Collaborated with business units to address operational challenges, ensuring alignment with quality objectives.

Provided training and support to suppliers on quality expectations, resulting in improved supplier performance.

Advocated for continuous enhancement of supplier quality systems, leading initiatives that significantly reduced defect rates.

Associate Quality Engineer, Trivitron Healthcare, Chennai, Tamil Nadu, India Jun 2013 – Aug 2015

Supported the execution of validation protocols to ensure compliance with medical device standards throughout the product lifecycle.

Collaborated with R&D and manufacturing teams to ensure adherence to regulatory requirements and internal quality processes.

Assisted in the implementation of electronic batch record (EBR) systems, enhancing traceability and reducing human error.

Worked on a Lean Initiative to streamline inspection workflows, cutting down process cycle time.

Developed internal training materials for process validation and risk management, increasing team competency.

Conducted root cause analysis for nonconformities, leading CAPA initiatives that improved product reliability.

Developed and maintained essential documentation to support risk management activities and regulatory compliance.

Conducted internal audits to verify compliance with industry regulations, contributing to the enhancement of quality systems.

Participated in continuous improvement initiatives focused on optimizing processes and product quality in medical device manufacturing.

Engaged with suppliers to ensure the quality of incoming components, contributing to the overall safety and efficacy of medical devices.

Assisted in analysing quality data to identify trends, providing insights to inform quality improvement strategies.

Supported the development of quality metrics to monitor performance and drive continuous improvement initiatives.

Provided training and support for team members on quality processes and compliance requirements, fostering a culture of quality awareness.

Education

Master of Science in Mechanical Engineering, California State University, Fullerton, USA - 2016

Bachelor of Science in Mechanical Engineering, NIT Trichy, Tamil Nadu, India - 2014

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