Katalyst CRO
Posted 74 days agoVerified live 2d ago
Quality Engineer
Brief overview
Remote
UndergradOr in progress
1+ yrsMinimum
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
cGMP requirementsComplaint handlingRoot cause analysisCAPA processesQuality systemsStatistical toolsMinitabTechnical drawings interpretationMS OfficeANSI standardsISO standardsASQC standardsContinuous improvement methodologiesProcess controlsMedical device regulatory compliance
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 supporting quality and compliance in the medical device industry. They are seeking a Quality Engineer to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated manufacturing environment.
Responsibilities
- Review customer complaints and associated service data to determine risk levels and identify problem/cause codes
- Conduct complaint investigations and perform detailed root cause analysis
- Analyze data from quality systems including Complaints, Field Corrective Actions (FCA), FDA MDRs, and other quality inputs to identify trends and systemic issues
- Prepare investigation summaries, reports, and recommendations based on analysis
- Review existing investigation reports and identify GMP compliance gaps
- Support development and implementation of corrective and preventive actions (CAPA)
- Drive continuous improvement initiatives and process control activities
- Conduct data analysis using statistical and quality tools
- Support maintenance activities for existing product lines and quality systems
- Collaborate cross-functionally to improve product quality and compliance standards
Skills
- Bachelor's degree in engineering (B.E./B.Tech or equivalent)
- 1–3 years of experience in the Medical Device industry
- Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements
- Experience in complaint handling, investigations, and root cause analysis
- Familiarity with CAPA processes and quality systems
- Strong analytical and problem-solving skills
- Experience with statistical tools/software such as Minitab is a plus
- Ability to read and interpret technical drawings and engineering documentation
- Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases
- Ability to manage multiple tasks and projects effectively
- Experience with ANSI/ISO/ASQC standards
- Exposure to continuous improvement methodologies and process controls
- Knowledge of medical device regulatory environments and compliance practices
Qualifications
Must Haves
- Bachelor's degree in engineering (B.E./B.Tech or equivalent)
- 1–3 years of experience in the Medical Device industry
- Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements
- Experience in complaint handling, investigations, and root cause analysis
- Familiarity with CAPA processes and quality systems
- Strong analytical and problem-solving skills
- Experience with statistical tools/software such as Minitab is a plus
- Ability to read and interpret technical drawings and engineering documentation
- Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases
- Ability to manage multiple tasks and projects effectively
Nice to Haves
- Experience with ANSI/ISO/ASQC standards
- Exposure to continuous improvement methodologies and process controls
- Knowledge of medical device regulatory environments and compliance practices
