Senior Specialist - Device Quality Engineering

April 3

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Simplify

Simplify is a comprehensive job search platform designed to streamline and enhance the job hunting process. By leveraging a single profile, users can access personalized job recommendations, craft tailored resumes, and efficiently track job applications. Offering tools like an AI Resume Builder, Autofill Application Extension, and Job Tracker, Simplify supports job seekers at every stage of their journey. The platform is free, with premium features available via subscription, and it earns revenue from companies that post or promote job openings. Simplify operates as a hiring marketplace, connecting candidates with exclusive opportunities while emphasizing user data privacy and security.

πŸ“‹ Description

β€’ Responsible for independent support of development and commercialization of Medical Devices β€’ Interact with cross functional teams β€’ Ensure compliance with applicable Medical Device Regulations and internal requirements β€’ Audit and approve DHF documentation

🎯 Requirements

β€’ Extensive knowledge of applicable medical device regulations (21CFR820, MDD, ISO 13485:2016) β€’ Risk Management Experience (ISO 14971:2012) β€’ Ability to work independently and in teams β€’ Excellent interpersonal and communication skills β€’ Preferred: Remediation experience, Regulatory Affairs Experience, Certified Lean Six Sigma Green Belt or Black Belt

πŸ–οΈ Benefits

β€’ Retirement savings plan β€’ Paid vacation and holiday time β€’ Paid caregiver/parental and medical leave β€’ Health benefits including medical, prescription drug, dental, and vision coverage

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