Recor Medical-posted 3 months ago
$153,977 - $169,562/Yr
Full-time • Mid Level
Palo Alto, CA
Wholesale Trade Agents and Brokers

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.

  • Lead and conduct supplier audits (ISO, GMP, FDA, etc.) based on annual schedules.
  • Evaluate and approve suppliers for inclusion in the Approved Supplier List (ASL).
  • Monitor supplier performance using KPIs.
  • Develop and implement supplier certification and re-certification programs.
  • Ensure supplier compliance with ISO 13485, 21 CFR 820, and other applicable regulations.
  • Maintain and improve Supplier Quality Management metrics and documentation.
  • Support CAPA investigations and non-conformance resolution related to supplier issues.
  • Facilitate Manufacturing Quality Agreements (MQAs) and ensure proper documentation.
  • Collaborate with R&D and manufacturing teams during design and process validation phases.
  • Provide input on statistical methods, test methodologies, and validation protocols.
  • Support process improvement initiatives and risk assessments using tools like FMEA and DOE.
  • Train internal teams and suppliers on quality tools and regulatory requirements.
  • Mentor junior engineers and support their development in supplier quality practices.
  • Investigate supplier-related complaints, MDRs, and recalls.
  • Coordinate corrective actions and ensure timely closure of audit findings.
  • Bachelor's or master's degree in engineering, Life Sciences, or related technical field.
  • 5-8+ years in Supplier Quality Engineering, preferably in medical devices or regulated industries.
  • Lead auditor experience with ISO 13485 and FDA QSRs.
  • Experience with CAPA, process validation, and statistical analysis.
  • ASQ CQE/CQA certification.
  • ISO 13485 Lead Auditor certification.
  • Six Sigma Green/Black Belt certification.
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