Quality Engineer II
Core
Prepare and compile post-market data into Periodic Safety Update Reports (PSURs) for medical devices, ensuring regulatory compliance and mentoring junior engineers.
Role type
Mid-level Quality Engineer (Medical Devices)
Builds
Regulatory safety reports (PSURs/CERs) and quality system documentation for medical device products
Domain
Healthcare technology, Medical Devices, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Post-market surveillance, PSUR/CER authoring, EU MDR, Risk Management, Design Controls, ISO 13485, ISO 14971, 21 CFR part 820, CAPA, NCMR
Preferred skills
ASQ CQE/CQA/CSQE/CRE certification, ISO 9001/13485 Auditor certification, Lean Six Sigma Green/Black Belt, PMCF, IMDRF coding
Responsibilities
Draft and author PSUR/CER documents, collaborate with cross-functional teams on device safety data, partner with regulatory affairs for submissions, monitor evolving safety regulations, develop quality system templates and training, review deliverables for compliance, participate in audits
Seniority
Mid-level, hands-on IC with mentorship duties