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).

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 Responsibilities

• 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.

Education and Experience

• 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.

Knowledge and Skills

• 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 importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

US BD 1st Shift 8am-430pm (United States of America)