Quality Engineer 1, EU MDR
BD
Summary
BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.
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.
Requirements
- Bachelor degree in STEM (Science, Technology, Engineering, Math)
- 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
Company overview
BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.