Katalyst CRO
Posted 67 days agoVerified live 2d ago
Product Quality Engineer
Brief overview
Remote
32 H-1B approvalsDept. of Labor
9 green cardsCertified filings
Product Quality EngineeringQuality Management SystemsCAPARoot Cause AnalysisFMEARisk ManagementStatistical Process ControlSPCStatistical AnalysisLean ManufacturingSix SigmaMinitab
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 seeking a Product Quality Engineer to ensure product quality throughout the entire product lifecycle. The ideal candidate will collaborate with cross-functional teams to establish quality requirements, drive continuous improvement, investigate product quality issues, and ensure compliance with industry and regulatory standards.
Responsibilities
- Support product quality activities throughout the product lifecycle, including design, development, manufacturing, and sustaining engineering
- Develop and implement quality plans, inspection criteria, and product acceptance requirements
- Collaborate with Design Engineering, Manufacturing, Operations, Supply Chain, and Regulatory teams to ensure product quality objectives are achieved
- Participate in New Product Introduction (NPI) and New Product Development (NPD) projects
- Perform risk assessments using DFMEA, PFMEA, Risk Analysis, and Control Plans
- Lead investigations for product quality issues using Root Cause Analysis tools such as 8D, 5 Whys, and Fishbone
- Manage Non-Conformance Reports (Client), Corrective and Preventive Actions (CAPA), Deviations, and Change Controls
- Analyze quality metrics, product performance, warranty data, and customer complaints to identify improvement opportunities
- Support Design Verification (DV), Design Validation (PV), Process Validation (IQ/OQ/PQ), and product qualification activities
- Ensure compliance with Quality Management Systems (QMS) and applicable regulatory standards
- Review engineering changes and assess their impact on product quality
- Work closely with Supplier Quality teams to resolve supplier-related quality issues
- Perform statistical analysis using SPC, Cp/Cpk, MSA, Gauge R&R, and Minitab or similar tools
- Support internal, customer, and regulatory audits
- Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies
Skills
- Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Manufacturing Engineering, Electrical Engineering, Chemical Engineering, or a related field
- 3–8+ years of experience in Product Quality Engineering or Quality Assurance within a regulated manufacturing environment
- Experience supporting product development and manufacturing quality activities
- Strong knowledge of Quality Management Systems (QMS)
- Experience with CAPA, Client, Root Cause Analysis, FMEA, and Risk Management
- Working knowledge of SPC, statistical analysis, and quality improvement methodologies
- Excellent analytical, problem-solving, communication, and collaboration skills
Qualifications
Must Haves
- Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Manufacturing Engineering, Electrical Engineering, Chemical Engineering, or a related field
- 3–8+ years of experience in Product Quality Engineering or Quality Assurance within a regulated manufacturing environment
- Experience supporting product development and manufacturing quality activities
- Strong knowledge of Quality Management Systems (QMS)
- Experience with CAPA, Client, Root Cause Analysis, FMEA, and Risk Management
- Working knowledge of SPC, statistical analysis, and quality improvement methodologies
- Excellent analytical, problem-solving, communication, and collaboration skills
