Quality Manager, Post-Market Surveillance

Job Description Summary

Job Description Summary

The Quality Manager is responsible for the post market surveillance, periodic quality data monitoring using statistical techniques, and risk management processes as well as provides Quality Engineering and Quality Assurance technical expertise and functional support to execute the processes in compliance with applicable regulations including FDA, and international regulations, ISO standards, and any other requirement that apply to the post market surveillance of the products manufactured by BD Urology & Critical Care (UCC).

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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.

• Manages the post market surveillance (PMS) process including the schedule of product reviews, coordination of updates to documentation, management of actions generated from the reviews and publishes the reviews in the EDMS.
• Coordinates with R&D, Clinical, Medical Affairs, Regulatory Affairs and Quality to facilitate completion of the PMS reports for each product family.
• Acts as a technical expert in PMS and risk management.
• Interfaces with the UCC manufacturing facilities and other business units as required to execute the PMS program and ensure risks are being evaluated and identified, and appropriate controls are being executed.
• Prepare and implement policies and procedures relating to quality, post market surveillance, risk controls and statistical techniques throughout product lifecycle in compliance with regulations.
• Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
• Maintains the integrity of all quality documentation.
• Responsible to maintain the training requirements for staff, including job position requirements, and evidence of training completion for associates.
• Responsible to meet quality objective goals as defined annually in support of monthly and quarterly metrics and business strategies.
• Provide Quality Engineering technical support to assist in resolving quality issues.
• Participate and have membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the business in an efficient, timely, and accurate manner.
• Participate in cross-functional team(s) to ensure that PMS, risk, and statistical techniques documentation is prepared and meets new regulatory requirements.
• Represents UCC in the BD network for PMS, risk and statistical techniques.
• Interfaces and responds to regulatory agencies as necessary.
• Oversee the design and implementation of analytical business and technology solutions, i.e., MS Access databases, R, SQL programs, Python, Power BI to support QM Operations.
• Oversee the use of quality metric data into Quality Management Review
• Support audits as a Subject Matter Expert for PMS, Risk Management and Statistical Techniques.

• BS degree required in Engineering, Science, or Technical field, higher education a plus.
• Minimum of 5 years, 8-10 years preferred of Quality Management System experience in a medical device or pharma or other regulated industry (medical device is preferred).
• Previous supervisory experience preferred.
• Experience using analytics / BI packages (e.g., SAS, R, SQL, Cognos, Business Objects, Power BI) to build client analysis solutions is preferred.
• ASQ, CQE, and CQA Certifications preferred.

• Experience in data analysis, trending and presenting data in a manner to drive informed decision making.
• Strong…