Quality and Testing Director - Digital Unit

Job Description

We are seeking a senior level leader for the Olympus Digital Unit to head quality and testing related activities as we continue to accelerate our global Digital journey.  As a global leader, you will play a key role on our leadership team and will be responsible for our overall quality direction which will include areas such as managing and evangelizing Software Development Lifecycle (SDLC) processes, assessing and improving these in line with industry standards, regulations, and best practices.   This role will require close collaboration with stakeholders across multiple functions including corporate QA and RA, product development and testing, privacy, security, program, and product management.  The ideal candidate should have a deep understanding of software development in medical device industry, be current on regulations, and understand modern practices for system and software verification, validation, and release methodology.   Strong communication, leadership, and negotiation skills along with a proven track record of delivering of software medical devices to the market will help you be successful in this role.

This role requires subject matter expertise in industry standards, including IEC 62304, IEC 82304, ISO 14971, ISO 81001-5-1 among others, as well as in various regulatory domains including FDA, EU-MDR and PMDA.   Additionally, this role will lead Digital Unit’s verification and validation processes and activities to ensure that product is released on schedule and on quality. 

Job Duties

• Create a “quality” culture within organization by identifying educational opportunities, providing guidance, and interpreting processes and regulations into practical implementations.
• Provide guidance and direction to software development teams on relevant quality processes and practices including SaMD , Cloud, and general health software.
• Collaborate with corporate QA / RA and other stakeholders to develop and maintain Quality Management System documents to ensure appropriate level of controls in conjunction with Agile software development practices.
• Provide leadership to testing teams, understand verification and validation testing methodologies and implement risk based best practices.
• Work with other technical leads within Digital Unit to coordinate processes, activities, and deliverables.  Define and support strategic directions and tactical activities. Represent Olympus Digital R&D during internal and external inspection and audits.  Establish a response framework for queries and audit findings.
• Collaborate across Olympus to monitor and understand software medical device regulations, guidance, and standards globally, including US, Japan, EU, and UK.  Incorporate these, as applicable, into Quality Management System processes and work instructions.
• Understand and lead development team quality and regulatory deliverables during development activities, such as development collaboration and co-creation, beta releases and production releases.

Job Qualifications

Required: 

• Bachelor's degree in related discipline, such as quality, information technology, engineering or related is preferred with equivalent experience acceptable. Advanced degree is preferred.
• Minimum of 14 years’ experience in the fields of software development, testing, quality, system engineering or related.
• Knowledge and experience of applications of software related regulations, such as IEC 62304, IEC 82304, ISO 14971, ISO 81001-5-1.  
• Experience in creation of internal process documentation, such as SOPs and WI adhering to the government and industry regulations. 
• Experience in creating submission materials in various regulatory domains including FDA, UE-MDR and PMDA. 
• Occasional travel may be required.

Preferred:

• Software medical device experience preferred.
• Quality management / leadership of software development organization preferred.
• Global experience preferred.
• Demonstrated capabilities to provide quality related leadership to multinational diverse R&D community in a collaborative, coaching, mentoring, and influencing capacity.
• Demonstrated capabilities to work effectively in cross-functional areas such as R&D, Quality, and Regulatory Affairs.
• Experience working on global, matrixed organization is preferred.
• Awareness of system engineering approaches and processes is preferred.
• Experience in application of relevant standards to software as a medical device and healthcare software and software platform.
• Experience in interfacing with Regulatory Authorities is preferred.
• Good understanding of system and software verification and validation processes and testing, including automated and workflow testing, preferably within an agile framework.
• Experience and understanding of risk management process and regulations and practical application of it to software systems.
• Excellent written and verbal communication skills. Ability to clearly communicate expectations, provide clear and honest feedback, and identify areas for improvement.