Director, Global Product Quality Assurance, Digital Products Development

$160,530 - $240,005/Yr

Otsuka America - New York, NY

Full-time - Senior

New York, NY

Computer and Electronic Product Manufacturing

About the position

The Director, Global Product Quality Assurance, Digital Products Development at Otsuka Precision Health is responsible for overseeing the quality assurance processes for digital devices and products. This role involves ensuring compliance with manufacturing and development regulations, developing quality management systems, and leading the Quality Assurance team. The director will collaborate with various teams to integrate quality into product development and support regulatory submissions, while also monitoring quality metrics and continuous improvement initiatives.

Responsibilities

• Provide oversight and expertise in the interpretation and implementation of manufacturing and development regulations applicable to digital devices.
• Develop and maintain SOPs to ensure compliance with GxP regulations.
• Contribute to the regulatory growth and standardization of quality processes at OPH.
• Develop OPH's Quality Management System for medical device hardware and SaMD product development.
• Lead design control and risk management activities for medical devices.
• Establish quality post-market surveillance activities and oversee performance monitoring for non-regulated products.
• Lead the Quality Assurance team and collaborate with cybersecurity, risk management, design quality, IT security, and human factors teams.
• Integrate quality into product development and deployment processes.
• Support internal and external audits and serve as the quality lead for regulatory submissions.
• Monitor and report metrics on quality and corporate compliance initiatives.

Requirements

• 10 years of Quality Management experience with GxP-compliant product development, manufacturing, and distribution.
• Expertise in FDA 21 CFR Parts 820, Part 4 and ISO 13485.
• 5 years of experience in internal/external auditing.
• Ability to manage team members and prioritize multiple tasks.
• Experience using MS Word, Excel, Electronic Document Management System, and Access.
• Experience with Agile Methodologies and Software Development.
• Knowledge of HIPAA and GDPR.

Nice-to-haves

• Internal Auditor Certificate for 21 CFR 820/ISO 13485 quality management system.
• Experience with ETQ.
• Experience with tools like JIRA, ServiceNow, Salesforce, and GRC tooling.

Benefits

• AD&D insurance
• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• Tuition reimbursement
• Paid time off
• Vision insurance
• 401(k) matching
• Prescription drug insurance