Director of Global Product Quality Assurance for Digital Products

2 weeks ago


Denver, United States Otsuka Full time
About Otsuka Precision Health

Otsuka Precision Health (OPH) is a health technology and services organization on a mission to get people the right interventions at the right time in their health journey through data and technology. We apply the power of personal connection and deep, data-driven understanding of the patient condition. OPH is part of Otsuka Holdings.

We are seeking a Director, Global Product Quality Assurance, Digital Products Development to provide oversight and expertise to OPH in the interpretation and implementation of manufacturing and development regulations applicable to digital devices (SaMD) and other products. The successful candidate will ensure that SOPs describing internal processes are developed to maintain compliance with GxP regulations. They will contribute to OPH's regulatory growth and standardization of quality processes.

The ideal candidate will have 10 years of Quality Management experience with GxP-compliant product development, manufacturing, and distribution. They will have expertise in FDA 21 CFR Parts 820, Part 4, and ISO 13485. The candidate will also have 5 years of experience in internal/external auditing and be able to manage supplier audits. They will have the ability to manage team members and prioritize multiple tasks. Experience in using MS Word, Excel, Electronic Document Management System, and Access is required. Experience with Agile Methodologies and Software Development is also preferred. Knowledge of HIPAA and GDPR is a must.

The successful candidate will be responsible for developing OPH's Quality Management System for medical device hardware and SaMD product development in compliance with applicable U.S. Federal Regulations, ISO 13485 standards, and other quality requirements. They will lead design control and risk management activities and establish quality post-market surveillance activities for medical devices. They will also oversee performance monitoring for non-regulated products and lead the Quality Assurance team. The candidate will collaborate with cybersecurity, risk management, design quality, IT security, and human factors teams to provide support for the commercial development and launch of digital devices and products. They will also support the Total Product Lifecycle as a contributing member, ensuring adherence to quality requirements. The candidate will support internal and external audits, respond to requests for information on quality activities, and serve as the quality lead for regulatory submissions and engagement with regulatory agencies. They will monitor and report metrics on quality and corporate compliance initiatives, ensuring continuous improvement. The successful candidate will also support OPH engagement with FDA and other regulatory agencies and support compliance programs.

This is a challenging and rewarding opportunity to join a dynamic team and contribute to the growth and success of Otsuka Precision Health. If you are a motivated and experienced professional with a passion for quality and regulatory compliance, we encourage you to apply.

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