Nirmala Srinivasan
Irvine
Summary
Results driven Quality Engineer with over a decade of experience in new product development and released product support. A collaborative professional recognized for exceptional organizational, communication, and interpersonal skills that foster a productive work environment. Successfully guided project teams through updated quality and regulatory processes, ensuring adherence to compliance to standards and project timelines.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Senior Quality Engineer(Released Product)
Medtronic
07.2020 - Current
- Quality point of contact for sustaining neurovascular device(design changes, regulatory submissions, CAPA)
- Own risk management activities
- Extensively guide design and development teams through modifying designs (including medical device with software).
- Planning and executing test method validation activities for achieving reliability on existing inspection methods.
- Support product failure investigations, CAPA ownership. Perform standard assessments to ensure compliance, lead implementation activities on labeling updates, procedural updates, support submissions and follow up activities.
- Collaborate with production, manufacturing/process engineering and R&D to resolve non-conformances, process issues, and help implement changes.
- Support internal/external audits and enable following up and closing out findings.
- Mentoring junior engineers with every day tasks
Senior Quality Engineer
Avanos Corporation
11.2018 - 06.2020
- Quality lead for new product development for acute pain medical devices.
- Developing the risk management files(Hazard analysis, FMEAs) with a cross functional team.
- Managing collaboration with a development partner to ensure all design control deliverables are identified and allocated appropriately.
- Managing activities for Design Transfer (DMR documentation) and Production Readiness activities(involving a contract manufacturer).
- Guiding the project team on Software quality activities- Software Development Life Cycle Process, planning software V&V testing, software issue tracking and defect management.
- Leading or supporting activities as needed such as (1) remediation,(2) CAPA’s, (3)change management action items.
- Conducting DHF audits to demonstrate high degree of assurance that product meets requirements & specifications, and to ensure that all required documentation is complete prior to final transfer to production.
- Participating and supporting internal audits.
- Mentoring new hires for the team to help navigate systems and guide appropriately to help grow in their roles.
Quality Engineer
Masimo Corporation
11.2015 - 11.2018
- Provide quality engineering expertise on design controls, verification, and validation in specific and, review manufacturing process implementation activities for new product development.
- Develop and maintain design history file for new product release and review design changes on existing products.
- Provide technical quality support for design reviews, and approval of product/process changes.
- Provide support to develop all risk management reports assessing hazards, corrective actions, and their effectiveness in compliance with ISO 14971. (UFMECA,DFMEA, PFMEA) including risk assessments for clinical study protocols.
- Provide support in failure analysis and help improve design/process issues.
- Provided support and feedback in procedural updates for company procedures relating to design control, supplier quality and software development.
- Identify and escalate areas of potential non-compliance (gap analysis,quality system document).
- Trained/mentored contractors and interns hired within the team to help efficiently contribute to the team and company.
Design Quality Engineer
Philips Healthcare
09.2014 - 10.2015
- Provide support and implement design controls throughout Product Development Process, for Class II medical devices.
- Support the new product development team to ensure Quality assurance in technology development, and release to manufacturing.
- Work closely with product development engineering, clinical, marketing and regulatory to assure appropriate reliability requirements are defined for the specific device application
- Compliance assessments of DHF (Design History File) and other program files for audits to ensure quality and regulatory requirements are met.
- Ensuring timely closure of defects within a specific function post risk analysis, investigation, solution implementation, verification and validation.
Associate Quality Engineer
Invacare Corporation
03.2013 - 09.2014
- Lead a team of 5 complaint handling investigators to help support ongoing CAPA requests, investigations and monitoring complaint trends.
- Initiated and participated in risk management activities such as remediation of DFMEA and PFMEA on sustaining engineering projects.
- Investigated and analyzed customer complaints, manufacturing, and field failure by using different statistical approaches to monitor complaint trends, and to maintain compliance with the complaint system.
- Lead root cause investigation, documentation for CAPAs and reported updates to upper management in a timely manner.
- Represented quality while working in a cross-functional team to drive changes related to complaints, product development, and engineering changes.
Supplier Quality Engineer
Invacare Corporation
11.2012 - 03.2013
- Ensured that the supplier quality systems met Invacare requirements and coordinated activities with the supplier as needed to place them on the Approved Supplier List.
- Participated/managed non-conformance request related to supplier non-conformance identified in manufacturing as well as product verification testing lab.
- Conducted effective root-cause investigations assessments of corrective action strategies and effectiveness as applied to non-conformance requests and supplier change approval requests.
- Developed and reviewed supplier documentation for conformity and quality assurance as part of FDA remediation activity.
Education
Master of Science - Biomedical Engineering
The University of Akron
Akron, OH, USA08.2012
Bachelor of Engineer - Electronics & Instrumentation Engineering
Anna University
India05.2009
Skills
- Quality System Regulation
- Audit readiness
- Corrective and Preventive Action
- Risk Management Leadership
- Verification and Validation
- Regulatory Knowledge
- Project Management
Certification
- Design Controls Series-Certification program (Xavier QARA Institute) – Oct 2015
- Software Verification & Validation Strategies 2019-Noblitt & Rueland
Timeline
Senior Quality Engineer(Released Product)
Medtronic
07.2020 - Current
Senior Quality Engineer
Avanos Corporation
11.2018 - 06.2020
Quality Engineer
Masimo Corporation
11.2015 - 11.2018
Design Quality Engineer
Philips Healthcare
09.2014 - 10.2015
Associate Quality Engineer
Invacare Corporation
03.2013 - 09.2014
Supplier Quality Engineer
Invacare Corporation
11.2012 - 03.2013
Bachelor of Engineer - Electronics & Instrumentation Engineering
Anna University
Master of Science - Biomedical Engineering
The University of Akron