Open to opportunities

Shruti Doctor

@shrutidoctor

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Quality Engineer with expertise in regulatory compliance and product development.

Zimbabwe

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What I'm looking for

I am looking for opportunities that allow me to leverage my quality engineering expertise while contributing to innovative projects in a collaborative environment.

I am a dedicated Quality Engineer with extensive experience in ensuring regulatory compliance and quality assurance in the medical device industry. Currently, I serve as a Quality Engineer at Ananya Health, where I am the subject matter expert on quality matters throughout the design and development process. My role involves educating team members on regulatory requirements and industry standards, as well as participating in the design and development of innovative medical devices like the CRCL device.

Previously, I worked at BioCircuit Technologies, where I oversaw the design and development of Nerve Tape™ and managed various quality assurance activities, including complaint investigations and CAPA processes. My experience at Becton Dickinson further honed my skills in quality assurance, where I was responsible for supporting the Endourology product family and ensuring compliance with regulatory standards. I have a proven track record of managing quality systems, conducting risk assessments, and participating in audits to maintain high-quality standards.

Experience

Work history, roles, and key accomplishments

Current

Quality Engineer

Current

Ananya Health

Jan 2025 - Present (6 months)

Served as the subject matter expert on Quality matters and issues throughout the design and development process, educating team members on regulatory requirements and industry standards. Participated in the design and development of the CRCL device and developed the eQMS system to fit the company's needs.

Quality Assurance Regulatory Compliance Risk Management ISO 13485

Quality Engineer

BioCircuit Technologies (BCT)

Oct 2023 - Present (1 year 9 months)

Served as the subject matter expert on Quality matters and issues, educating team members on regulatory requirements and industry standards. Participated in the design, development, and maintenance of Nerve Tape™, overseeing design and development activities through product launch and assisting with post-launch product maintenance.

Quality Assurance Regulatory Compliance Risk Management Supplier Management

Quality Engineer II

Becton Dickinson (BD)

Mar 2020 - Present (5 years 4 months)

Responsible for all quality assurance decisions and activities supporting the Endourology product family, including Stone Basket/Graspers/Forceps and Single Use Endoscopes. Managed quality sustaining activities such as complaint investigation, CAPA, non-conformance, and regulatory maintenance including MDSAP and EU MDR remediation.

Quality Assurance Regulatory Compliance CAPA Risk Management Supplier Management EU MDR MDSAP ISO 13485

Quality Engineer I

Becton Dickinson (BD)

Jun 2018 - Present (7 years 1 month)

Supported quality management systems (QMS) in post-market surveillance by authoring and updating local and corporate procedures to maintain compliance with EU MDR and FDA-CFR-801/ISO 13485. Authored new risk documentation related to products becoming EU MDR compliant and analyzed post-market activities.

Quality Management Systems EU MDR ISO 13485 Compliance Management

Quality Assurance Specialist II

AbbVie Pharmaceuticals

Jan 2017 - Present (8 years 6 months)

Managed the receipt and processing of complaints associated with Humira drug and devices through TrackWise and ARISg systems. Dispositioned information within complaints according to FDA-CFR 820 & 803 to ensure compliance with company procedures using the CAPA database.

Quality Assurance FDA CFR 803 CAPA Trackwise Compliance

Education

Degrees, certifications, and relevant coursework

University of Iowa

Bachelor of Science in Engineering, Biomedical Engineering

Activities and societies: Hand Built Bicycle project (Aug-Dec 2015): Used basic engineering principles to ensure a structurally sound project by performing fatigue testing using ABAQUS and checking for any fail/fracture points in the material and design. Crafted bike frame using fabrication and design techniques in AutoCad to give it a customized and creative look.

Completed a Bachelor of Science in Biomedical Engineering. Gained foundational knowledge in engineering principles and their application to biological and medical systems.