Quality Engineer II jobs in United States
cer-icon
Apply on Employer Site
company-logo

Redbock - an NES Fircroft company ยท 8 hours ago

Quality Engineer II

Redbock, an NES Fircroft company, is a thriving medical device organization seeking a Quality Engineer II for MES deployment, validation, and maintenance activities. The role involves documenting requirements, planning and executing MES validation, and supporting training strategies.

BiotechnologyConsultingMedical DevicePharmaceutical
check
Growth Opportunities
check
H1B Sponsor Likelynote
Hiring Manager
Kalyn Burer
linkedin

Responsibilities

Document revising and authoring for MES requirements, SOPs, PFMEAs, control plans and training
MES validation planning and execution and ongoing compliance maintenance
Training strategy support
Other duties, as required

Qualification

FDA regulationsComputer system validationMES deploymentISO 13485 complianceTechnical Bachelor's degreeHP ALMChange management

Required

3+ years of relevant experience in FDA-regulated industries, performing computer system validation, writing and executing test cases and supporting software system deployment for FDA-regulated manufacturing operations
Solid understanding of ISO 820-13486 compliance
Relevant technical Bachelor's degree

Preferred

Experience validating, deploying and maintaining MES and eDHR systems is highly preferred
Solid change management and HP ALM experience is a big plus

Company

Redbock - an NES Fircroft company

twittertwittertwitter
company-logo
Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.

H1B Sponsorship

Redbock - an NES Fircroft 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
2025 (8)
2024 (5)
2023 (1)
2022 (1)
2021 (8)
2020 (9)

Funding

Current Stage
Growth Stage
Total Funding
unknown
2018-06-20Acquired
Company data provided by crunchbase