Director of Global Product Quality Assurance for Digital Products
2 weeks ago
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.
-
Director of Global Product Quality Assurance
4 weeks ago
Denver, Colorado, United States Otsuka Full timeAbout Otsuka Precision HealthOtsuka Precision Health 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, applying the power of personal connection and deep, data-driven understanding of the patient condition.Job DescriptionWe are seeking a...
-
Director of Global Product Quality Assurance
4 weeks ago
Denver, NY, United States Otsuka Full timeAbout Otsuka Precision HealthOtsuka Precision Health 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, applying the power of personal connection and deep, data-driven understanding of the patient condition.Job DescriptionWe are seeking a...
-
Denver, United States Otsuka Full timeAbout Otsuka Precision Health Founded on Otsuka's rich history in delivering creative innovations for patients, Otsuka Precision Health (OPH) is the next step in our evolution. We are a health technology and services organization on a mission. And that mission is to get people the right interventions at the right time in their health journey through data and...
-
Digital Product Director
4 weeks ago
Denver, Colorado, United States Frontier Airlines Full timeAbout the RoleFrontier Airlines is seeking a highly skilled and experienced Senior Director, Digital & Omnichannel Product to lead our digital product teams in delivering a best-in-class omnichannel technology platform. As a key member of our leadership team, you will be responsible for defining the strategy and roadmap for digital products, leading...
-
Associate Director Quality Assurance
4 weeks ago
Denver, Colorado, United States Eli Lilly Full timeJob Title: Associate Director Quality AssuranceAt Eli Lilly, we are committed to delivering high-quality products that meet the needs of our customers. We are seeking an experienced Associate Director Quality Assurance to join our team.Job Summary:The Associate Director Quality Assurance will be responsible for leading the quality assurance team in ensuring...
-
Director of Quality Assurance
6 days ago
Denver, NY, United States Otsuka Full timeAbout Otsuka Precision HealthWe are 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, applying the power of personal connection and deep, data-driven understanding of the patient condition.The Director, Global Product Quality Assurance,...
-
Digital Product Manager
1 month ago
Denver, Colorado, United States Frontier Careers Full timeJob Title: Sr. Director, Digital & Omnichannel ProductAt Frontier Airlines, we're seeking a highly skilled and experienced Sr. Director, Digital & Omnichannel Product to lead our digital product teams in delivering industry-leading self-service capabilities across platforms and products. As a key member of our commercial team, you will be responsible for...
-
Digital Product Strategist
1 week ago
Denver, Colorado, United States Frontier Airlines Full timeJob SummaryAs the Sr. Director, Digital & Omnichannel Product, you will lead the development and execution of Frontier Airlines' digital product roadmap, driving innovation and growth across all commercial platforms and channels. This role requires a strategic thinker with expertise in digital product management, e-commerce, and airline commercial metrics...
-
Product Manager
3 weeks ago
Denver, Colorado, United States Insight Global Full timeProduct Owner Job DescriptionWe are seeking a highly skilled Product Owner to join our team at Insight Global. As a Product Owner, you will be responsible for driving the development and execution of our product vision, strategy, and stakeholder alignment to deliver exceptional customer experiences through digital transformation.Key Responsibilities:Develop...
-
Quality Assurance Intern
6 days ago
Denver, Colorado, United States Dawn Food Products Full timeAbout the RoleDawn Foods is a leading bakery manufacturing and ingredients distribution company. As a global partner of choice, we help customers grow their business through meaningful partnerships, research-driven insights, and innovative products. As a family-owned company, our commitments to our people, products, customers, and corporate values are the...
-
Digital Transformation Product Manager
1 week ago
Denver, Colorado, United States Insight Global Full timeProduct Owner Role OverviewThe Product Owner is accountable for driving the development and execution of the organization's vision, strategy, and stakeholder alignment to enhance the customer experience through digital transformation.Key responsibilities include building new and strengthening existing relationships to ensure alignment with broader...
-
Quality Assurance Technician
2 weeks ago
Denver, Colorado, United States KIK Consumer Products Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Technician to join our team at KIK Consumer Products. As a Quality Assurance Technician, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesPerform and complete analytical methods in accordance with company procedures and project guidelines,...
-
Product Manager
3 weeks ago
Denver, Colorado, United States Insight Global Full timeProduct Owner Job DescriptionAn exciting opportunity has arisen for a Product Owner to join our team at Insight Global. As a key member of our organization, you will be responsible for driving the development and execution of our product vision, ensuring alignment with our strategic objectives and delivering exceptional customer experiences.Key...
-
Product Manager
2 weeks ago
Denver, Colorado, United States Insight Global Full timeProduct OwnerAt Insight Global, we're seeking a seasoned Product Owner to join our team and drive digital transformation for one of our top Utility clients. As a key member of our organization, you'll be responsible for developing and executing the vision, strategy, and stakeholder alignment necessary to deliver on our priority to enhance the customer...
-
Quality Assurance Supervisor
1 month ago
Denver, United States Nestle Purina PetCare Company Full timeWe re a leader in the pet care industry, which means we re not only ahead in volume, profit and market share, but our associates dare to Stand Taller. We innovate new products, impart new agilities into existing processes, constantly advance pet nutrition, and always pay it forward in the form of service for our communities and families. Are you up for the...
-
Product Manager
2 weeks ago
Denver, Colorado, United States LG Ad Solutions Full timeAbout UsLG Ad Solutions is a global leader in connected TV (CTV) and cross-screen advertising. We pride ourselves on delivering state-of-the-art advertising solutions that integrate seamlessly with today's ever-evolving digital media landscape.The OpportunityWe are seeking an experienced Product Manager to join our Data Products team. This individual will...
-
Senior Program Manager
1 month ago
Denver, Colorado, United States Freshworks Full timeJob Title: Senior Program ManagerWe are seeking a highly skilled Senior Program Manager to join our Digital Product team at Freshworks. As a Senior Program Manager, you will be responsible for overseeing and managing quarterly planning with our stakeholders to understand their needs, while working with resource managers to allocate resourcing toward top...
-
Quality Assurance Tech I- Nights
4 weeks ago
Denver, United States Dawn Food Products Full time_ Dawn Foods is a global leader in bakery manufacturing and ingredients distribution. As the partner of choice for inspiring bakery success, we helpcustomers grow their business through meaningful partnerships, research-driven insights and innovations, and products and expertise they can depend on. As a family-owned company, our commitments to our people,...
-
Operations Supervisor
1 week ago
Denver, Colorado, United States gategroup Full timeJob SummaryWe are seeking a highly motivated and experienced Operations Supervisor to join our team at gategroup. As a key member of our operations team, you will be responsible for ensuring the highest standards of food safety and quality assurance in our manufacturing facilities.Key ResponsibilitiesSupervise a team of employees to ensure compliance with...
-
Quality Assurance Specialist
2 weeks ago
Denver, Colorado, United States Saxon Global Full timeJob Title: Quality Assurance SpecialistA quality assurance specialist is responsible for ensuring the quality of software products by identifying and analyzing defects. They develop and execute test plans, identify and document defects, and collaborate with software developers to resolve issues.Key Responsibilities:* Develop and execute test plans to ensure...