Sindhu Mahadevan

Operations Associate

Toronto, Ontario, Canada6 yrs 5 mos experience

Most Likely To SwitchHighly Stable

Key Highlights

7+ years in medical devices Quality Assurance
Expertise in ISO 13485 and risk management
Passionate about empowering newcomers in Canada

Stackforce AI infers this person is a Quality Assurance expert in the Medical Device and Pharma industries.

Contact

mahadevansindhu@gmail.com LinkedIn

Skills

Core Skills

Quality AssuranceQuality Management SystemRisk Management

Other Skills

Design History FileMedical DevicesQuality System Compliance21 CFR 820Standard Operating Procedure (SOP)Product DevelopmentGood Manufacturing Practice (GMP)Quality Assurance DocumentationRegulatory ComplianceChange ControlQuality ManagementEquipment ManagementWork InstructionsCritical ThinkingTechnical Writing

About

I wear two hats. My professional passion is medical devices Quality Assurance. I’m a Medical device QA professional with 7+ years. I’ve worked with Class III, IIb medical devices and IVD devices, building strong quality systems in both startups and large corporations. For me, quality isn’t about checkboxes; it’s about patient safety, culture, and trust. My personal passion is to help newcomers get access to the BEST information. I’m an immigrant who rebuilt her career in Canada. I know what it feels like to start over, navigate paperwork, and wonder if your skills will ever get recognized. That’s why I write about Canadian immigration and career growth with clarity, so newcomers don’t feel lost like I once did. What I bring to the table: Quality Expertise → ISO 13485, ISO 14971, risk management, design control, non-conformances Industry Focus → Medical Device, Pharma, and Biotech Immigrant Insights → Practical guidance for PR, job hunting, and building a life and career in Canada Through my newsletter, This Immigrant Life, I break down Canadian immigration in simple words, clear, honest, and without the fluff. 👉 Subscribe here: https://open.substack.com/pub/sindhum?r=1tgb3n&utm_medium=ios Let’s connect, whether it’s to elevate quality culture in life sciences or to help newcomers thrive in Canada.

Experience

6 yrs 5 mos

Total Experience

2 yrs 1 mo

Average Tenure

4 yrs 6 mos

Current Experience

Vital bio

2 roles

Quality Assurance Team Lead

Promoted

Nov 2023 – Present · 2 yrs 6 mos · Greater Toronto Area, Canada

Established 15+ fundamental processes at Vital - including Design & Development procedures.
Led Quality Planning activities - including drafting the Design and Development Plan and other QA
initiatives (Quality Policy, Quality culture campaign, alignment with suppliers) etc.
Owned continuous improvement of the QMS with expertise in ISO 13485, 14971, 21 CFR Part 820.
Ownership of: Document control, Change Control, Non-conformance, Out of Specification and Deviation at Vital
Ownership of employee training – including onboarding training determination, tracking and compliance.
Function as the QA Subject Matter Expert in cGMP implementation

Design History FileMedical DevicesQuality System Compliance21 CFR 820Standard Operating Procedure (SOP)Quality Assurance+1

Quality Assurance Associate

Nov 2021 – Nov 2023 · 2 yrs · Greater Toronto Area, Canada

Started the Quality function at a vibrant diagnostics start-up with 100+ employees.
Built 10+ fundamental QMS processes like Document Management, Change Control, Health and Safety, Change Control, Design and Development with cross-functional collaboration
Selected, established and validated an eQMS platform.
Created training content and actively trained a workforce of 100+ employees in fundamental Quality processes like Quality Culture, Root Cause Analysis, eQMS usage, Equipment maintenance, WHMIS, Biosafety etc.
Created a collaborative Preventative maintenance program across a research and development team covering 1000+ equipment across a team of 70+ scientists, engineers and other technical personnel.
Built an appreciation for and understanding of Quality Assurance processes among peers and higher management.
Built cross-functional relationships to build a strong Quality culture in a start-up environment leading to strong collaboration on Quality deliverables and objectives.

Product DevelopmentGood Manufacturing Practice (GMP)Quality Assurance DocumentationRegulatory ComplianceChange ControlQuality Management+6

Prantae solutions

Consultant- Quality Assurance/ Quality Systems

Mar 2020 – Oct 2021 · 1 yr 7 mos

- Helped build a bootstrapped ISO 13485- compliant QMS as well as an ISO- 14971 compliant Risk Management Process for a diagnostics start-up company, including providing a Quality architecture for critical processes like product design, verification and validation, risk management, supplier management process, non-conformance reporting etc.

Work InstructionsCritical ThinkingTechnical WritingQuality AssuranceQuality Management System

Bd

Quality Engineer/ Analyst

Jan 2017 – Oct 2018 · 1 yr 9 mos · Andover, MA

Supported the development of a Class IIb Medical device by providing critical Quality Engineering support in Verification/ validation activities and product risk management with focus on continuous improvement of internal quality processes.
Oversaw V/V activities of an offshore team of engineers as the design owner.
Acted as Quality SME in Design Reviews for a critical combination product, leveraging quality expertise as well as life sciences background.

Product DevelopmentGood Manufacturing Practice (GMP)Quality Assurance DocumentationRegulatory ComplianceChange ControlQuality Management+4

Medtronic ltd

Safety Engineer/ Analyst

May 2015 – Jan 2017 · 1 yr 8 mos · Mounds View, MN

Served as point person for Project Risk Management for four Class 3 Medical Device projects.
Created and maintained Risk Management Plans, Reports, Hazard Analysis, collaborating with technical, regulatory, manufacturing and other functions.
Performed Risk Management File Remediation for CE mark re-certification.
Provided critical Risk Management feedback to Clinical Evaluation Reports for currently marketed products.

Good Manufacturing Practice (GMP)Quality Assurance DocumentationRegulatory ComplianceQuality ManagementCritical ThinkingTechnical Writing+2

Emr it llc

Intern

Feb 2015 – Apr 2015 · 2 mos · Nashua, NH

Training in various aspects of Quality Assurance in the context of Medical Device and Pharma industry. Gaining knowledge on product lifecycle and applicable FDA quality regulations.

Critical Thinking