Katalyst CRO ยท 2 months ago
Design Quality Engineer
Franklin Lakes, NJ
Contract
Onsite
Senior Level
7+ years expKatalyst CRO is involved in the medical device industry, and they are seeking a Design Quality Engineer to lead and support design verification and validation activities. The role includes ensuring compliance with regulatory standards and collaborating with cross-functional teams to enhance product quality.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead and support design verification and validation activities, including test method development and execution
Perform sample size selection and statistical data analysis to support design decisions and risk assessments
Conduct process capability studies and support design transfer to manufacturing
Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards
Collaborate with cross-functional teams including R&D, Regulatory, and Manufacturing
Review and approve design documentation including Design History Files (DHF), risk management files and test protocols
Provide technical guidance and mentorship to junior QEs offshore
Support CAPA investigations related to design issues and contribute to continuous improvement initiatives
Qualification
Required
7 years of experience in medical device industry
Lead and support design verification and validation activities, including test method development and execution
Perform sample size selection and statistical data analysis to support design decisions and risk assessments
Conduct process capability studies and support design transfer to manufacturing
Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards
Collaborate with cross-functional teams including R&D, Regulatory, and Manufacturing
Review and approve design documentation including Design History Files (DHF), risk management files and test protocols
Provide technical guidance and mentorship to junior QEs offshore
Support CAPA investigations related to design issues and contribute to continuous improvement initiatives
Quality Engineer (CQE) or equivalent certification
Experience with software tools such as Minitab, JMP, or similar statistical analysis platforms
Familiarity with risk management standards (ISO 14971) and usability engineering (IEC 62366)
Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part 820)
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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