A bit about us:

We're an IVD start-up based in Menlo Park, CA. We are looking for a Senior Director of Quality that has a broad vision for Quality with the ability and willingness to build systems and procedures while also developing a growing team.

Sound like you? Apply today!

Location: REMOTE (Based in Menlo Park, CA)

Why join us?

  • Start up culture with great stock options
  • Full benefits

Job Details

You will be accountable for the performance of the Quality Management System and quality organization including customer satisfaction, on-time delivery, compliance, labeling, relationships with suppliers, customers, talent management, and effective communications related to quality initiatives.

<b> Qualifications: </b>
  • Degree in life science.
  • A minimum of ten (10) years of experience implementing and/or maintaining quality management systems in an FDA GMP or ISO-13485 regulated industry setting.
  • At least seven (7) years of management experience in regulated software and/or in vitro diagnostics medical device companies with both domestic and international products.
  • In-depth knowledge of and experience with FDA Quality System Regulation (QSR) with an emphasis on Process Validation; Design Control; Supplier Control; GMP/GLP, ISO-13485, ISO 14971, 21 CFR 820. 30, EU In Vitro Diagnostics Directive/In Vitro Diagnostics Regulation, and other medical device (IVD) regulations.
  • Experience building and leading high performing teams, including direct-report managers.
  • Proven ability to lead cross-functional teams in problem-solving and continuous process improvement.
  • Experience with medical device (IVD) systems, software, consumable and reagent development.

<b> Responsibilities </b>
  • Collaborate with R&D, Product, and Operations to develop targets for new and existing products.
  • Lead and support process improvement projects and ensure quality, and compliance processes and metrics are met and support the needs of the customers.
  • Serve as the Management Representative for the company - managing and maintaining the effectiveness of the Quality Management System (QMS) and facilitating the awareness of regulatory and customer requirements throughout the organization.
  • Lead and develop the Quality team which comprises quality assurance, documentation/change control and quality engineering.
  • Establish the QMS to ensure on-going compliance with FDA's QSR/GMP requirements and any other applicable regional in vitro diagnostic regulations, including achieving and maintaining ISO-13485 registration.
  • Develop and Implement a Quality Strategic Plan for supporting multiple regulated and unregulated applications of our mobile application and cloud platform.
  • Partner with suppliers, contract manufacturers and distributors to secure the highest level of quality throughout the entire supply chain.
  • Serve as the primary point of contact with the Company's notified body/external auditor and with regulators, partnering with external regulatory advisors on new filings.
  • Drive continuous monitoring and process improvements.
  • Work with cross-functional leadership to ensure all aspects of product development and delivery are performed in conformance to the QMS and regulatory requirements.
  • Improve customer satisfaction through quality initiatives and process improvement.


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