Sreejith Viswam

Director of Engineering

Bengaluru, Karnataka, India25 yrs 11 mos experience

Highly Stable

Key Highlights

Led Quality and Regulatory teams across APAC.
Developed Quality Strategy for new product developments.
Managed FDA inspections with zero enforcement actions.

Stackforce AI infers this person is a Healthcare Quality Assurance and Regulatory Affairs expert.

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Skills

Core Skills

Quality ManagementRegulatory AffairsQuality AssuranceRegulatory ComplianceQuality ComplianceDesign ControlProcess QualityProduct QualityDesign TransferQuality EnhancementsLean Concepts

Other Skills

LeadershipQuality AuditingSoftware Quality AssuranceSupplier QualityRegulatory SubmissionsRegulatory RequirementsRegulatory ReportingRegulatory DocumentationGlobal Regulatory ComplianceQuality management systemU.S. Food and Drug Administration (FDA)CE markingCDSCOMedical Device Regulation (MDR)Medical Device Directive

Experience

25 yrs 11 mos

Total Experience

10 yrs 7 mos

Average Tenure

4 yrs 9 mos

Current Experience

Stryker

3 roles

Director- Innovation Enablers (RAQA, Test Lab and R&D Operations)

Jan 2026 – Present · 4 mos

Honored to share that I will be leading the newly formed group of Innovation Enablers at Stryker Global Technology Center (SGTC). This group will focus on building efficiencies and drive collaboration across Test Lab, RAQA and R&D Operations team and bring synergies to accelerate innovation at SGTC working with R&D team. Grateful for this wonderful opportunity to drive my next chapter at SGTC.

Quality AssuranceQuality ManagementLeadershipQuality AuditingSoftware Quality AssuranceSupplier Quality+15

Director- Quality and Regulatory Stryker Global Technology Center and APAC NPD

Mar 2023 – Jan 2026 · 2 yrs 10 mos

Director- Quality and Regulatory and Management Representative for Stryker Global Technology Centre and APAC NPD at Stryker
Responsible for providing Leadership and Direction for implementation of QMS and Certification for Stryker Global Technology Centre
Management Representative for Stryker Global Technology Centre
Responsible for providing Leadership and Direction to ensure Quality, regulatory and Compliance targets for Asia Pacific new product development.
Develop, Lead and execute Quality Strategy for new product developments, sustainment and post market requirements, ensure customer quality expectations and business needs are met.
Ensure cross functional alignment by collaborating with Quality and Regulatory teams, R&D, Service, Global Quality & Regulatory organization, Finance, Sales and Marketing departments to ensure corporate goals, compliance and develop best practices to drive revenue through improved customer experience.
Manage supplier Quality Process for all products owned by SGTC

Quality ManagementSoftware Quality AssuranceLeadershipQuality AuditingSupplier QualityRegulatory Affairs+16

Director- Quality and Regulatory APAC New Product Development at Stryker

Aug 2021 – Mar 2023 · 1 yr 7 mos

Director- Quality and Regulatory APAC New Product Development at Stryker
Responsible for providing Leadership and Direction to ensure Quality, regulatory and Compliance targets for Asia Pacific new product development.
Develop, Lead and execute Quality Strategy for new product developments, sustainment and post market requirements, ensure customer quality expectations and business needs are met.
Ensure cross functional alignment by collaborating with Quality and Regulatory teams, R&D, Service, Global Quality & Regulatory organization, Finance, Sales and Marketing departments to ensure corporate goals, compliance and develop best practices to drive revenue through improved customer experience.
Manage supplier Quality Process for all products.

Quality ManagementLeadershipRegulatory AffairsQuality AuditingSupplier QualityQuality Assurance+13

Ge healthcare

6 roles

Senior Site Total Quality Manager

Jul 2019 – Aug 2021 · 2 yrs 1 mo

Key member of the Site Leadership team developing strategies & direction
Responsible for the Quality Assurance & Product Quality for the Site
Lead and drive Quality Culture at Site and enable Total Quality engagement.
Build, Retain and Develop a vibrant Quality team at site
Collaborate & enable a positive culture & mindset with cross functional team
Responsible to enable product quality/ improvement while maintaining safety and regulatory compliance.
Face of site for the regulators and notified bodies- Management Rep for Site
Set and deliver site compliance and Product Quality metrics
Manage Inspections & Audits including FDA, NMPA, KFDA, Anvisa, MHLW, MDSAP, ISO 13485 etc
Drive targeted strategic external influencing, execute critical requirements at site and ensure no enforcement actions

Quality AssuranceLeadershipQuality ManagementRegulatory ComplianceFDANMPA+5

Senior Site Quality Manager

Mar 2018 – Jul 2019 · 1 yr 4 mos

Key member of the Site Leadership team developing strategies & direction
Responsible for the Quality Assurance for the Site
Develop team and Promote a culture of urgency and Speed
Collaborate & enable a positive culture & mindset with cross functional team
Responsible for Quality Compliance at Site
Face of site for the regulators and notified bodies- Management Rep for Site
Manage Inspections & Audits including FDA, NMPA, KFDA, Anvisa, MHLW, MDSAP, ISO 13485, ISO 9001 etc

Quality AssuranceLeadershipQuality ComplianceFDANMPAKFDA+5

Senior Manager-Quality

Promoted

Oct 2015 – Mar 2018 · 2 yrs 5 mos

Manage the Design Control QA team and set direction and strategies for NPIs and Design changes for 10+ Business Vertical under CCS and Imaging.
Deliver On time NPIs and critical Design changes
Partner with Site Quality Leader to manage FDA and other Inspections
First ever Design Only site FDA QSIT inspection across GE and closed with Zero 483s.
Build, Retain and realign Quality team responsibility for resource optimization.
Collaborate & enable a positive culture & mindset with cross functional team
Develop an expert Design Control team at site.

Quality AssuranceLeadershipDesign ControlFDAInspectionsQuality Management

Team Leader- Process & Quality

Feb 2012 – Sep 2015 · 3 yrs 7 mos

Manage the Process and Product Quality teams at Site
Deliver On time NPIs and critical Design changes
Partner with Site Quality Leader to manage FDA and other Inspections
Responsible for the product Quality & Process engineering teams
Drive excellence by building expertise, multi skilling and productivity/ simplification
Retain top talents, Develop next line of leaders by effective mentoring
Drive other modality initiatives and projects based on business priorities

Process QualityProduct QualityQuality AssuranceFDAInspections

Quality Assurance Leader-Design Transfer

Feb 2008 – Mar 2012 · 4 yrs 1 mo

Support NPI team for Smooth design transfer & Jerk free ramp up w.r.t Quality and regulatory requirements.
Plan and Lead Product and Site certification audits for New Products
Conducting Quality Audits on QMS, products & processes to ensure adherence to QMS and quality requirements
Set up QMS requirements from scratch for new business models- refurbishment
Develop a design transfer process for the site.
Collaborate & enable a smooth introduction of NPIs from QMS compliance

Quality AssuranceDesign TransferQuality AuditsQMS

Senior Process Engineer

Jul 2005 – Jun 2007 · 1 yr 11 mos

Lead and Mentor Action Workouts for implementing lean concepts and Quality enhancements.
Develop and Improve Standardized Work Instructions/procedures
Set up the mfg line, capacity analysis, design, validate & install equipments & fixtures
Modality SME for audits
New model Introductions at site
Preparation of all product related documents to comply with ISO 9001 Standard
Development of alternate sources & Support suppliers to improve process quality
Preparation and monitoring of inspection procedure and sampling plan for IQC.

Lean ConceptsQuality EnhancementsISO 9001