Job Description Summary

Under the Sr. Manager, Complaint Management, the Quality System Specialist I – Data Analyst supports and maintains data management systems to monitor the effectiveness of the Unit Quality system. The position will be responsible for supporting and maintaining quality systems data, developing and testing software solutions, and coordinating the implementation of quality data management strategies with business application teams. The position will also be responsible for assuring the integrity, accuracy, and compliance of data collected and presented to business functions (e.g. Management review, internal customers, external customers, auditors, post market surveillance etc).

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Summary:

Under the Sr. Manager, Complaint Management, the Quality System Specialist I – Data Analyst supports and maintains data management systems to monitor the effectiveness of the Unit Quality system. The position will be responsible for supporting and maintaining quality systems data, developing and testing software solutions, and coordinating the implementation of quality data management strategies with business application teams. The position will also be responsible for assuring the integrity, accuracy, and compliance of data collected and presented to business functions (e.g. Management review, internal customers, external customers, auditors, post market surveillance etc).

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Develops and maintains systems to transform raw data from enterprise databases to meaningful reports and dashboards.

• Ensures that all standard data summaries are statistically valid.  Assists and educates users in running and interpreting results from these reports.

• Responds to internal and external requests for data through the preparation of ad-hoc queries and reports.

• Participates in cross functional projects for metric assignment and reporting to senior leadership for the improvement of customer experience and satisfaction.

• Work with IT to analyze the requirements with respect to system capabilities to identify functionality gaps. Work with IT lead to write and test functional specifications for the enhancements.

• Provide functional and technical expertise to business process owners for design application, change management, training and roll out plans.

• Partner with IT Business Intelligence to ensure smooth operation of the department dashboards.

• Designs, develops, documents and implements validation test plans to address installation, operational, and performance qualifications requirements for unit, systems and integration testing.

• Identify, plan, coordinate and perform database design as needed, development and implementation to meet business objectives and drive continuous improvement to meet customer expectations.

• Pursue and maintain a functional knowledge of global regulations

• Develop policies and procedures as appropriate to comply with ISO 13485, GMP 21 CFR Part 820 and Electronic Records/Electronic Signature regulation 21 CFR Part 11

• Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors and establish key stakeholder engagement focused on win-win solutions.

• Monitors the integrity of Quality Data management Systems and coordinates with IT support to resolve issues in a timely manner.

Education and Experience:

• B.S. in Information Systems, Computer Science or Science related field and 2-3 years’ experience.

• Experience working in a regulated environment or the healthcare industry strongly preferred

​Knowledge and Skills:

• Experience and expertise with quality data analysis and statistics (SPC, Pareto charts, etc.)

• Strong interpersonal skills, demonstrated capability of working on multiple projects at one time.