Job summary
Job post source
This job is from a recruiting firm hiring for a separate company based on the company name Katalyst CRO, which suggests a contract research organization likely recruiting for clients.
Job overview
The Supplier Quality Engineer role involves ensuring supplier quality and compliance within a regulated medical device environment, impacting production and product quality.
Responsibilities and impact
The candidate will perform root cause analysis, validations, FMEAs, NPI, design control, and supplier quality management, with a focus on medical devices and regulated quality standards.
Experience and skills
Requires at least four years of relevant experience, hands-on production line validation experience, knowledge of NC/CAPA, FMEAs, NPI, design control, and supplier quality; experience with J&J is preferred; critical thinking and strong communication skills are essential.
Company overview
Katalyst CRO is a contract research organization specializing in providing comprehensive clinical trial management and support services to pharmaceutical, biotechnology, and medical device companies. They generate revenue by offering tailored solutions in clinical operations, regulatory affairs, data management, and biostatistics to accelerate drug and device development processes. Founded with a focus on innovation and efficiency, Katalyst CRO emphasizes collaboration and cutting-edge technology to deliver high-quality results. Their expertise spans multiple therapeutic areas, making them a trusted partner in advancing healthcare solutions globally.
How to land this job
Position your resume to highlight at least four years of relevant experience in supplier quality engineering, especially emphasizing hands-on production line experience with validations and familiarity with medical device regulations.
Focus on showcasing skills in NC/CAPA root cause analysis, FMEAs, NPI, Design Control, and supplier quality management, as these are core to the role.
Apply through multiple channels including Katalyst CRO’s corporate careers page and LinkedIn to maximize your application visibility.
Connect with current employees in the quality or supplier quality divisions at Katalyst CRO on LinkedIn; use ice breakers like asking about their experience with medical device quality standards or mentioning your interest in how they manage supplier quality challenges.
Optimize your resume for ATS by incorporating keywords from the job description such as 'NC/CAPA root cause analysis,' 'validations,' 'FMEAs,' 'Design Control,' and 'medical device' to ensure it passes automated screenings.
Leverage Jennie Johnson’s Power Apply feature to automate tailoring your resume, identify multiple application platforms, and find relevant LinkedIn contacts, allowing you to focus your time on preparing for interviews and networking effectively.
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