Katalyst CRO
Posted 74 days agoVerified live 1d ago
Quality Engineer
Brief overview
Remote
UndergradOr in progress
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Gage Repeatability and Reproducibility (Gage R&R)Measurement System Analysis (MSA)Statistical data analysisMinitabDimensional inspectionPrecision measurement equipmentEngineering drawings interpretationGeometric Dimensioning and Tolerancing (GD&T)Inspection methodologiesSampling plansQuality engineering principlesFDA Quality System RegulationsISO 13485Microsoft ExcelMicrosoft WordMicrosoft PowerPointASQ Certified Quality Engineer (CQE)
About the company
Katalyst CROkatalysthls.com
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
Visa sponsorship history
4 years sponsoring, last filed FY2026
Data powered by U.S. Department of Labor. This does not guarantee sponsorship for this specific role.32H-1B approved
89%approval rate
3new H-1B hires
9PERM certified
$240,000median wage / yr
H-1B Petition ApprovalsVisas USCIS actually granted: the strongest sign the company sponsors.
202319
20249
20254
LCA Certified ApplicationsAn early filing step, not a visa approval: it signals intent, not confirmed sponsorship.
20236
20242
20259
20262
Green Card (PERM) FilingsCertified green card filings: a long-term commitment to international hires.
20235
20241
20253
Top sponsored roles
VALIDATION ENGINEERQUALITY ENGINEERCLINICAL DATA ANALYSTPRODUCT DEVELOPMENT ENGINEERCLINICAL DATA MANAGER
Sponsored employees from
India
Job description
Summary
Katalyst CRO is a company focused on quality assurance in the manufacturing sector, and they are seeking a Quality Engineer to ensure product compliance with specifications. The role involves performing inspections, developing inspection plans, and analyzing measurement systems to enhance quality processes.
Responsibilities
- Perform incoming and first article inspections of to verify conformance to specifications and quality requirements
- Utilize precision measurement equipment including calipers, micrometers, height gages, optical comparators, Keyence, and other inspection tools to perform dimensional and visual inspections
- Review engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T) requirements to review appropriate inspection methods and acceptance criteria
- Develop, maintain, and improve inspection plans, sampling plans, inspection procedures, and product acceptance standards
- Plan, execute, analyze, and document Gage Repeatability and Reproducibility (Gage R&R) studies and other Measurement System Analysis (MSA) activities to ensure measurement system capability
- Evaluate measurement system performance and implement improvements to reduce measurement variation and improve inspection effectiveness
- Other duties as assigned
Skills
- Bachelor's degree in Engineering or a related technical discipline
- Experience conducting Gage R&R studies, Measurement System Analysis (MSA), and statistical data analysis
- Working knowledge of statistical tools and software, including Minitab or equivalent applications
- Experience performing dimensional inspections and utilizing precision measurement equipment
- Ability to interpret engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T)
- Knowledge of inspection methodologies, sampling plans, and quality engineering principles
- Strong analytical, problem-solving, and organizational skills
- Excellent written and verbal communication skills with the ability to effectively communicate technical information
- Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint
- Ability to work independently and collaboratively in a fast-paced, regulated manufacturing environment
- Two years of experience preferred
- Understanding of FDA Quality System Regulations, ISO 13485 requirements, and other applicable quality standards preferred
- ASQ Certified Quality Engineer (CQE) preferred
Qualifications
Must Haves
- Bachelor's degree in Engineering or a related technical discipline
- Experience conducting Gage R&R studies, Measurement System Analysis (MSA), and statistical data analysis
- Working knowledge of statistical tools and software, including Minitab or equivalent applications
- Experience performing dimensional inspections and utilizing precision measurement equipment
- Ability to interpret engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T)
- Knowledge of inspection methodologies, sampling plans, and quality engineering principles
- Strong analytical, problem-solving, and organizational skills
- Excellent written and verbal communication skills with the ability to effectively communicate technical information
- Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint
- Ability to work independently and collaboratively in a fast-paced, regulated manufacturing environment
Nice to Haves
- two years of experience preferred
- Understanding of FDA Quality System Regulations, ISO 13485 requirements, and other applicable quality standards preferred
- ASQ Certified Quality Engineer (CQE) preferred
