Quality Engineer , EU MDR

Position: Quality Engineer 1, EU MDR
We are the people who give possibilities purposeBD 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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description Responsibilities:

Develops physical and functional test requirements to assure specifications and regulations are met.

Writes, reviews, and approves protocols, reports, and data.

Conducts testing outlined in protocols and test methods.

Executes validation studies on equipment and processes, and conducts and/or participates in complaints investigations.

Understands and follows company procedures and regulatory requirements.

Participates in and provides input to training on department & division procedures, and policies.

Analyzes design, process, and test data.

Prepares and presents oral and written project updates and technical discussions.

Develops and implements procedures to provide easy to follow instructions. Develop sampling plans by applying attribute, variable, and sequential sampling methods. Develop local procedures, Test Methods, and standards.

Develop and implement Statistical Process Control.

Leads investigations related to quality problems.

Ability to define and manage risk-management plan, risk assessment and risk-control tools.

Facilitate or independently lead non-conforming product investigations, including corrective/preventive actions and product remedial actions.

Responsible for systems assurance including documentation, testing and inspection, and product and process development.

Will support Manufacturing, New Product Development, and Regulatory (as applicable) to ensure systems are in compliance with internal and external guidelines and regulations.

Identify and lead product and systems continuous improvement initiatives.

Communicate effectively at all levels within Quality, as well as cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, and other functions as necessary.

Execute design controls and analyzes design inputs.

Will participate in internal/external audits.

Minimum Qualifications:

Bachelor degree in STEM (Science, Technology, Engineering, Math), Preferred qualifications include:

Candidates with an engineering degree.

Candidates that have engineering experience within the medical device or equivalent regulated industry.

The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.

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?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins…