Quality Manager, Post-Market Surveillance

Job Description Summary

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

• 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 listening, assessment, questioning, analytical and problem-solving skills.

• Must consistently demonstrate critical thinking skills to manage inputs and outputs.

• Comprehensive knowledge of quality systems regulations, post market surveillance and risk management.

• Extensive knowledge of manufacturing.

• Ability to work independently with general direction and concurrence from senior management.

• Ability to participate and provide leadership to teams and maintain positive work environment.

• Knowledge, understanding and interpretation of FDA regulations, ISO standards, EU MDR and other industry standards for medical devices is required.

• Comprehensive knowledge of statistical techniques, investigation techniques, Quality Engineering principles, team functions, leadership techniques and project management methodologies.

• Ability to effectively manage time and multiple task assignments as well as managing team assignments and direction.

• Supports a strong culture of accountability and inclusion and seeks to develop team capabilities as well as foster personal growth.

• Strong interpersonal skills required in areas of verbal/written communications, customer focus, professionalism, coaching, team building, and leading.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the…