Working Location: Massachusetts, Westborough Workplace Flexibility: HybridJob DescriptionThe IT SD Product Owner - Complaint Handling is responsible for the global strategy, delivery, governance, and operational excellence of enterprise complaint handling solutions, with primary emphasis on TrackWise Digital. This role ensures technology solutions effectively support end-to-end complaint handling processes, regulatory compliance, product quality, and patient safety.
The IT Product Owner partners with Global Process Owners, Quality Assurance, Regulatory Affairs, and IT teams to define product strategy, manage the roadmap and backlog, prioritize business demands, and deliver scalable, secure, and validated solutions.
The role drives continuous improvement, platform modernization, and innovation through automation, AI-enabled capabilities, and system integration while ensuring alignment with enterprise architecture, regulatory requirements, and business objectives.
Job DutiesExperience Platform Strategy & Ownership- Define and maintain the global product strategy and roadmap for complaint handling solutions, primarily TrackWise Digital, aligning technology investments with business and IT priorities.
- Serve as the primary IT Product Owner for TrackWise Digital, ensuring solution integrity, standardization, scalability, regulatory compliance, and long-term sustainability.
- Partner with Global Process Owners and business stakeholders to prioritize enhancements, integrations, and new capabilities based on business value, regulatory requirements, and technical feasibility.
Solution Delivery & Architecture- Lead the end-to-end product lifecycle, including requirements, backlog management, solution design, development, testing, validation, deployment, and ongoing support using Agile methodologies.
- Collaborate with Solution Architecture, Enterprise Architecture, Security, Infrastructure, and Development teams to ensure solutions align with enterprise standards and regulatory requirements.
- Drive integration between TrackWise Digital and enterprise systems, including ERP, PLM, QMS, and regulatory applications, ensuring data integrity and end-to-end traceability.
Stakeholder & Vendor Management- Act as the primary IT liaison across Quality Assurance, Regulatory Affairs, Post-Market Surveillance, global IT teams, and external partners to align priorities, investments, and delivery.
- Manage TrackWise Digital vendors, implementation partners, and AMS providers, ensuring service quality, delivery commitments, operational performance, and SLA compliance.
Platform Operations & Continuous Improvement- Drive platform performance and continuous improvement through operational KPIs, workflow optimization, automation, analytics, and AI-enabled capabilities to improve complaint handling efficiency and quality.
- Ensure platform compliance with enterprise governance, cybersecurity, data integrity, computer system validation, and applicable regulatory requirements, including FDA QMSR, 21 CFR Part 11, ISO 13485, and EU MDR.
Other responsibilities / duties as assigned.
Job QualificationsRequired:- Bachelor's degree in Information Technology, Computer Science, Engineering, Business Administration, or related field (or equivalent experience).
- Minimum 8-10 years of experience in enterprise IT applications, quality management systems, or IT product ownership within a global organization.
- Knowledge of medical device complaint handling, post-market surveillance, and regulatory compliance (FDA, ISO 13485, EU MDR).
- Experience with Agile delivery, system integration, computer system validation, and application lifecycle management.
- Experience leading cross-functional IT teams and initiatives in a global, matrixed organization.
- Ability to manage competing priorities, influence stakeholders, and govern external vendors and service providers.
- Strong analytical, problem-solving, and decision-making skills.
- Effective communication, collaboration, and stakeholder management.
- Results-oriented, detail-focused, and adaptable.
Preferred:- Agile certification preferred.
- Experience with TrackWise Digital or legacy TrackWise products required; TrackWise Digital experience strongly preferred.
- Experience with AI, automation, and process improvement preferred.
Why join Olympus?We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive medical, dental, vision coverage effective on start date
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance*
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:- Work-life integrated culture that supports an employee centric mindset
- Offers onsite, hybrid and field work environments
- Paid volunteering and charitable donation/match programs
- Employee Resource Groups
- Dedicated Training Resources and Learning & Development Programs
- Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position in this location is $122,362.00 - $171,307.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
