Senior Medical Device Quality Engineer / Quality Manager jobs in United States
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MicroPort Cardiovascular · 4 weeks ago

Senior Medical Device Quality Engineer / Quality Manager

positionIrvine, CA
timeFull-time
remoteHybrid
seniorityMid, Senior Level
date3+ years exp

MicroPort Cardiovascular is seeking a Senior Medical Device Quality Engineer / Quality Manager to join their Irvine, CA team. This hybrid role combines leadership in Quality Management Systems with hands-on product and process quality engineering responsibilities, ensuring compliance and product quality throughout the lifecycle.

Medical Device
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H1B Sponsor Likelynote
Hiring Manager
Icey Liu
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Responsibilities

Develop, implement, maintain, and continuously improve the Quality Management System
Ensure compliance with applicable regulations and standards, including:
FDA 21 CFR Part 820 (QSR)
ISO 13485
ISO 9001 (as applicable)
Lead and support internal and external audits, including FDA inspections and Notified Body audits
Own document control, including SOPs, work instructions, and quality records
Manage CAPA, change control, management review, and quality metrics
Train personnel on quality system requirements and regulatory expectations
Ensure products and processes meet defined quality, regulatory, and customer requirements
Support design controls, including design verification, validation, and change management across the product lifecycle
Define and maintain:
Inspection and test methods
Quality control plans
FMEA and risk management (ISO 14971)
Support New Product Introduction (NPI) activities
Analyze product and process issues using root cause analysis tools (e.g., 8D, Fishbone, 5 Why)
Apply statistical quality tools such as SPC, Cp/Cpk
Oversee raw material quality evaluation, supplier quality activities, and product shelf-life verification
Review and audit product quality activities completed by other team members
Lead annual product risk management reviews

Qualification

FDA QSR / 21 CFR Part 820ISO 13485Medical device design controlsInternalExternal auditsStatistical quality toolsSolidWorksCAD toolsMandarin language proficiencyCommunication skills

Required

Bachelor's degree in Engineering or Science
3–5+ years of experience in medical device quality or quality assurance
Strong working knowledge of FDA QSR / 21 CFR Part 820
Strong working knowledge of ISO 13485
Strong working knowledge of medical device design controls and risk management
Experience supporting or leading internal and external audits (FDA, Notified Bodies, ISO)
Strong written and verbal communication skills

Preferred

Degree in Mechanical Engineering, Materials Science, or Polymer Science
Experience with catheter-based or implantable medical devices
Proficiency with SolidWorks or CAD tools
Mandarin language proficiency
Previous experience in a startup or fast-growing medical device environment

Company

MicroPort Cardiovascular

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Founded in 1998, as a company dedicated to making emerging minimally invasive technologies more accessible to more patients across the world.
dateFounded in 1998
location
Shanghai, Shanghai, CN
people-size1001-5000 employees
web-link
https://microport.com/healthcare-professional/cardiovascular

H1B Sponsorship

MicroPort Cardiovascular 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
2023 (1)

Funding

Current Stage
Late Stage
Company data provided by crunchbase