Shantha Samarasinghe
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Shantha Samarasinghe Email & Phone Number

Quality Engineering Leader in Medical Device & Healthcare at Abbott
Location: Maple Grove, Minnesota, United States 4 work roles 2 schools
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Current company
Role
Quality Engineering Leader in Medical Device & Healthcare
Location
Maple Grove, Minnesota, United States
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Shantha Samarasinghe is listed as Quality Engineering Leader in Medical Device & Healthcare at Abbott, a with 82486 employees, based in Maple Grove, Minnesota, United States. AeroLeads shows a matched LinkedIn profile for Shantha Samarasinghe.

Shantha Samarasinghe previously worked as Quality Engineering Manager at Abbott and Corporate Supplier Quality Engineering Lead at Ecolab. Shantha Samarasinghe holds Ph.D. from University Of Illinois At Urbana-Champaign.

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Abbott

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Profile bio

About Shantha Samarasinghe

An accomplished, results driven quality engineering leader with demonstrated success in navigating evolving medical device quality and regulatory landscape in skillful quality systems & supplier management, recruiting, hiring, and supervising top-performing teams. Proven aptitude in project management, audits, cross-functional teamwork, problem solving and critical thinking. New Product Introduction technical sourcing, audits, supplier development, evaluation and selection experience. Successfully executed business critical continuous improvement & supplier development projects in cross-functional environment.Knowledge & expertise includes:• ISO 9001, ISO 13485, 21 CFR 210, 211, 820• ISO 14971• MDSAP• Continuous improvement leader in supplier management• Manage supplier selection, evaluation & qualifications• Conduct supplier audits & assessments• Prepare & present scorecards and metrics• New product development• Hire, mentor & develop staff• Expertise in managing NCMRs, SCARs & CAPAs• Quality agreements & contracts• Lead auditor• Validation (IQ, OQ, PQ) experience• SAP, ERP system expertise• Cross-functional Project Manager

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Abbott
Abbott
Quality Engineering Leader in Medical Device & Healthcare
illinois, united states
Website
Employees
82486
AeroLeads page
4 roles · 25 years

Shantha Samarasinghe work experience

A career timeline built from the work history available for this profile.

Quality Engineering Manager

Current

United States

Manage engineering group for worldwide manufacturing locations responsible for supplier selection, evaluation, qualification, supplier corrective action (SCAR), supplier change notifications (SCN/SCR), supplier performance assessment & supplier development including new product introductions. Established risk based supplier categorization to ensure efficient resource utilization to achieve business objectives.• Led new component qualification, supplier evaluation & selection, process validation& supplier quote review for three business critical new product commercial launches.• Refined & improved quality metrics & scorecards to reflect true supplier performance and identify improvement opportunities.• Identified critical to quality (CTQ) specification remediation opportunities to improve manufacturability & cost reduction.• Led remediation efforts to build a robust supplier base for the business.• Built high performing supplier engineering team through hiring, mentoring & training.• Manage a team of engineers supporting all aspects of product lifecycle management.• Manage test method validations, inspection & testing laboratory for release testing & first article inspections etc.

2018 - Present ~8 yrs 7 mos

Corporate Supplier Quality Engineering Lead

United States

Supported worldwide manufacturing locations & new product introduction programs via supplier audits, supplier evaluation, selection, qualification, performance assessment & process validation. New Product Introduction technical sourcing, supplier development, evaluation and selection experience. Successfully executed business critical supplier development projects in cross-functional environment.• Developed & executed global supplier quality program and policies.• Managed CAPA, NCMR, SCAR & complaint handling systems to improve customer satisfaction.• Established risk based supplier management program to ensure effective resource utilization & outcome based reward system.• Established quality agreements & contracts to ensure compliance & business continuity.• Utilized metrics & scorecards to deliver consistent year over year improvements of supplier performance.

2013 - 2018 ~5 yrs

Lead Quality Engineer

Minnesota, United States

Program leader responsible for operations quality and continuous improvements. Established new quality manual, risk management process, metrics and scorecards.• Established & administered new CAPA & continuous improvement procedures• Led management reviews• Managed the internal audit program• Hosted external audits• Prepared and presented quality metrics• Established a state of the art quality system

2011 - 2013 ~2 yrs

Senior Principal Engineer (Quality Engineering & Regulatory Leader)

Minnesota, United States

Core team member responsible for design quality deliverables in new product introduction programs• Managed & supported design verifications & validations • Prepared, reviewed and submitted technical reports for regulatory submissions• Led risk management and risk analysis, FMEA, hazard analysis• Led test method development & validation• Regulatory submissions• Technical files

2002 - 2011 ~9 yrs
Team & coworkers

Colleagues at Abbott

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2 education records

Shantha Samarasinghe education

FAQ

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What company does Shantha Samarasinghe work for?

Shantha Samarasinghe works for Abbott.

What is Shantha Samarasinghe's role at Abbott?

Shantha Samarasinghe is listed as Quality Engineering Leader in Medical Device & Healthcare at Abbott.

Where is Shantha Samarasinghe based?

Shantha Samarasinghe is based in Maple Grove, Minnesota, United States while working with Abbott.

What companies has Shantha Samarasinghe worked for?

Shantha Samarasinghe has worked for Abbott, Ecolab, Greatbatch Medical, and Medtronic.

Who are Shantha Samarasinghe's colleagues at Abbott?

Shantha Samarasinghe's colleagues at Abbott include Oscar Vigueras Olvera, Al-Amin Abdul Aziz, Mudau Tuwani, Mary Adex, and Brahim Benallel.

How can I contact Shantha Samarasinghe?

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What schools did Shantha Samarasinghe attend?

Shantha Samarasinghe holds Ph.D. from University Of Illinois At Urbana-Champaign.

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