Supplier Quality Engineer with medical device jobs in United States
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HCLTech · 10 hours ago

Supplier Quality Engineer with medical device

positionMounds View, MN
timeFull-time
remoteOnsite
seniorityMid Level
money$38.46/hr - $52/hr
date4+ years exp

HCLTech is looking for a highly talented and self-motivated Supplier Quality Engineer to join it in advancing the technological world through innovation and creativity. The ideal candidate will have a strong background in medical device supplier quality, focusing on supplier qualification, PPAP documentation, and process validation.

Information and Communications Technology (ICT)IT ManagementOutsourcingSoftwareTelecommunications
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H1B Sponsor Likelynote

Responsibilities

Qualify suppliers in accordance with company standards
Manage and maintain the Approved Supplier List (ASL)
Manage and release all PPAP deliverables including Control Plans, MSA, PFMEA, FAI, etc., within the document control system
Support PPAP execution with suppliers and ensure robust process qualification/validation using IQ, OQ, and PQ methodologies
Define Receiving Inspection requirements
Validate test methods in alignment with internal
Work with cross-functional teams to develop and implement product acceptance sampling strategies
Deploy supplier quality tools such as PFMEA, MSA, control plans for both new and legacy products
Provide technical assistance to suppliers throughout the product/process qualification lifecycle
Collaborate with suppliers to address SCAPA/NCR issues in compliance with company standards

Qualification

Supplier Quality EngineeringPPAP DocumentationProcess ValidationISO 13485 CertificationFDA Standards FamiliarityCommunication SkillsProblem-Solving SkillsCross-Functional Teamwork

Required

Bachelor's degree in engineering or related field
Minimum 4+ years of experience in supplier quality engineering within the medical device industry
Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans
Familiarity with FDA and ISO 13485 standards
Excellent communication and problem-solving skills
Ability to work independently and in cross-functional teams

Preferred

ISO 13485 Certified Talent preferred by client

Benefits

Medical
Dental
Vision
Pharmacy
Life
Accidental death & dismemberment
Disability insurance
Employee assistance program
401(k) retirement plan
10 days of paid time off per year
10 paid holidays per year

Company

HCLTech

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HCLTech is a global IT company offering digital, engineering, and cloud solutions partnering with businesses for transformation.
dateFounded in 1976
location
Noida, Uttar Pradesh, IND
people-size10001+ employees
web-link
https://www.hcltech.com/

H1B Sponsorship

HCLTech has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2975)
2024 (3974)
2023 (3649)
2022 (3861)
2021 (4093)
2020 (4317)

Funding

Current Stage
Public Company
Total Funding
$220M
Key Investors
ChrysCapital
2008-07-10Post Ipo Equity· $220M
2000-01-06IPO

Leadership Team

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Vijayakumar C.
Chief Executive Officer
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Alan Flower
Executive Vice President - CTO & Global Head, AI & Cloud Native Labs
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Recent News

Hindu Business Line
HCLTech Q3 net profit falls 11.2% to ₹4,076 cr; revenue grows 13.3%
2026-01-13
Hindu Business Line
HCLTech reports 11.2% y-o-y profit dip in Q3 as new labour codes weigh on margins
2026-01-13
Canada NewsWire
The Magnum Ice Cream Company (TMICC),
2026-01-13
Company data provided by crunchbase