Job Description Summary

The Quality Engineer, Post-Market Program is primarily responsible for executing and coordinating the day-to-day operations of the post-market surveillance program and related processes. Additionally, this position executes various quality engineering tasks in support of Quality Assurance and Design Control. The successful candidate will work with teams in Quality, R&D and manufacturing to complete projects while growing expertise and gaining knowledge of products and processes within the business. All work product will follow FDA Quality System Regulations, other FDA regulations, ISO regulations, MDR regulations and international regulations that apply to the products manufactured by BD Urology & Critical Care (UCC).

THIS POSITION IS A HYBRID ROLE AND IS ON SITE 3 DAYS PER WEEK

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. 

The Position is a hybrid / on-site role.

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following.  Other duties may be assigned.

• Ensures post-market surveillance (PMS) activities are completed on time and in compliance with applicable regulations and company procedures.
• Responsible for maintaining the PMS procedures, accurate documentation and records, as well as data integrity according to internal requirements.
• Executes changes to the PMS process, as required, after sufficient collaboration with appropriate individuals.
• Coordinates with R&D, Clinical Affairs, Medical Affairs, Regulatory Affairs, Marketing, Manufacturing, and Quality to facilitate completion of the PMS Review process and builds productive cross-functional working relationships.
• Demonstrated ability to use common tools such as Word, Excel, PowerPoint, and various databases.
• Ability to discern when issues are to be escalated to manager for resolution.
• Ensures compliance to Business Unit, Segment and Corporate procedures as well as external laws and regulations.
• Participates 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.
• Travel is less than 10% as required to facilitate completion of duties and responsibilities.

QUALIFICATIONS

• Strong listening, assessment, questioning, analytical, and problem-solving skills.
• Ability to manage multiple assignments and projects concurrently. 
• Ability to perform detailed engineering work under the direction of a Senior Engineer and Management.
• Ability to participate in a team environment and exercise influence management. 
• Basic knowledge and understanding of FDA regulations, ISO standards, EU MDR and other industry standards for medical devices.
• Good knowledge of statistical techniques and Fundamentals of Engineering Principles.
• Supports a strong culture of accountability.
• Basic understanding of Design Control requirements and Risk Management as applied to medical devices.
• Strong interpersonal skills required in areas of verbal/written communications, customer focus, and professionalism.

EDUCATION/EXPERIENCE

• B.S. in Engineering, Science, or Technical field, is minimally required
• 1-3 years, experience with an FDA or similarly regulated industry required.
• 1-3 years, experience executing PMS activities is preferred.
• American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
• This position is required to partner and lead across nearly all functions within the Business Unit without direct reporting structures into those departments.  Influence and the ability to clearly define the business and compliance requirements are key to the success of the individual.

PHYSICAL REQUIREMENTS:

• The incumbent to sit for extended periods of time, stand and perform general office functions.

• They may be required to lift up to twenty-five pounds occasionally.

WORK ENVIORNMENT:

• Office environment.

• Manufacturing environments.

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