Katalyst CRO · 1 day ago
Quality Engineer
Bloomingdale, IL
Contract
Onsite
New Grad, Entry Level
0+ years expKatalyst CRO is a company focused on quality assurance in the medical device sector. They are seeking a Quality Engineer responsible for ensuring that cell processes are correctly base-lined and controlled, and for creating and improving quality systems to meet regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC
Supports the Material Review Board (MRB) for internal non-conformances and customer returns
May lead or verify effectiveness of corrective and preventive actions (CAPAs)
Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements
Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements
Qualification
Required
Responsible for ensuring cell processes are correctly base-lined & controlled
Supports the Material Review Board (MRB) for internal non-conformances and customer returns
May lead or verify effectiveness of corrective and preventive actions (CAPAs)
Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements
Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements
We need someone with technical experience with GD&T and knowledge of blueprint reading and being able to describe the symbols on a blueprint and what the symbols mean
CAPA, Root Cause Analysis
0-3 years' experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T
Working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulation
Preferred
Bachelor's Degree in Engineering or related field is preferred
Med device and Manufacturing experience is preferred
Company
Katalyst CRO
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.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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