Cathx Site Quality Lead jobs in United States
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CathX Medical. A Zeus Company. ยท 1 month ago

Cathx Site Quality Lead

positionArden Hills, MN
timeFull-time
remoteOnsite
seniorityLead/Staff

CathX Medical, a Zeus Company, is focused on ensuring quality and compliance within their manufacturing site. The Cathx Site Quality Lead will oversee quality staff, ensure adherence to regulatory requirements, and drive continuous improvement in manufacturing processes.

Medical Device
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H1B Sponsor Likelynote

Responsibilities

Ensure the effectiveness and continuous improvement of the manufacturing site to ensure customer satisfaction and achieve the quality policy objectives
Provide daily oversight to the Quality staff at the manufacturing site with the exception of the Design assurance engineers
Ensure compliance with 21CFR820, ISO 13485, and EU MDR 2017/745 (the requirements) as applicable to CathX at the manufacturing site
Oversee the following activities at the site for on-time completion and compliance with requirements:
Inspection, measuring and testing
Nonconforming materials
Complaints and RMA
Corrective and preventive action
Gemba walks and LPA
Equipment and process validation
Facility maintenance
Environmental monitoring and testing

Qualification

Quality AssuranceISO 1348521CFR820EU MDR 2017/745Process Validation

Required

Ensure the effectiveness and continuous improvement of the manufacturing site to ensure customer satisfaction and achieve the quality policy objectives
Provide daily oversight to the Quality staff at the manufacturing site with the exception of the Design assurance engineers
Ensure compliance with 21CFR820, ISO 13485, and EU MDR 2017/745 (the requirements) as applicable to CathX at the manufacturing site
Oversee the following activities at the site for on-time completion and compliance with requirements: Inspection, measuring and testing, Nonconforming materials, Complaints and RMA, Corrective and preventive action, Gemba walks and LPA, Equipment and process validation, Facility maintenance, Environmental monitoring and testing

Company

CathX Medical. A Zeus Company.

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CathX Medical (A Zeus Company) offers medical device companies and OEMs a single source for design engineering services, rapid prototyping, manufacturing, and full or sub-assemblies.
dateFounded in 2020
location
San Jose, California, US
people-size11-50 employees
web-link
https://www.cathxmed.com

H1B Sponsorship

CathX Medical. A Zeus Company. 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 (2)

Funding

Current Stage
Early Stage

Leadership Team

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Suresh Sainath
President & Co-Founder
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Company data provided by crunchbase