Global Senior Quality Business Analyst

Working Location: PENNSYLVANIA, CENTER VALLEY; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK 

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Senior Business Analyst is a Subject Matter Expert (SME) that will play a pivotal role in transforming, organizing, and continuously improving quality system processes and information managed through global systems and tools that support the Quality Management System at Olympus. This role focuses on providing management insights, visibility, and governance to the quality system globally. The SME will collaborate closely with global project teams to ensure the fulfillment of stakeholder requirements. They will assist Global Process Owners (GPO) and the Project Management Office (PMO) in project management efforts to maintain schedules and ensure task completion. The role will be responsible for translating business needs into requirements, facilitating user validation, conducting end-user training, authoring system and process documentation, performing data analysis, and actively engaging with stakeholders.

Job Duties

• Serves an as subject matter expert, understanding business requirements and technical capabilities of the business system tools to be developed or in use.
• Conduct in-depth analysis of existing business processes, systems, and data to identify areas for improvement.
• Utilize data analysis tools and techniques to extract, clean, and analyze data from various sources to identify trends, patterns, and anomalies in data to inform decision-making.
• Collaborates with business users, internal technology teams across Olympus and vendors to establish and prioritize business and technology requirements.
• Leads gathering and documenting business requirements with stakeholders globally.
• Analyses the feasibility of, and develops requirements for, new systems and enhancements to existing systems; from a business and technology perspective to ensure the system design fits the needs of the users. 
• Translates business requirements into clear and comprehensive functional specifications that are understandable to the end-users. 
• Change agent to facilitate effective deployment of business systems.  Work with and manage complex workflows as they pertain to business process.
• Assists in the development of validation documentation (i.e., IQ, OQ, PQ, and UAT).
• Provides training, guidance, and is a resource support for end users.
• Supports defining project requirements by identifying project milestones, phases, and elements.
• All Other Essential Duties as assigned by Management. 

Job Qualifications

Required:

• BA/BS medical, engineering, scientific discipline.
• 5 years of related experience analyzing, clarifying, and translating business requirements into functional and technical specifications.
• Experience supporting or working within a pharma, medical device, or any other regulatory controlled industry.
• Background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003, and Canadian Medical Device requirements. 
• Proficiency in data analysis tools and techniques (e.g., SQL, Excel, data visualization tools); Competent understanding of International medical device regulations.
• Competent with Microsoft Office 365 Suite, Visio, Adobe, DocuSign, Agile and Windows platforms.
• Global working hours.

 

Preferred:

• Black Belt / Green Belt, Continuous improvement techniques and/or demonstrated problem-solving and root cause techniques is a plus. 
• Industry certifications (e.g., CBAP, PMI-PBA) are beneficial.
• Strong analytical, critical thinking, and problem-solving driving proactive solutions.
• Knowledge of business application testing approaches.
• Excellent communication and presentation skills.
• A motivated self-starter that is able to work independently and in teams on tasks and projects with limited supervision.
• Project management experie