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

Develop, implement, and maintain Quality System procedures, Standard Operating Procedures (SOPs), and quality policies.
Lead and execute validation activities, including change validations and recurring process/equipment qualifications for Media plants and IDAST.
Monitor, trend, and analyze quality indicators for purchased materials, manufactured products, and distributed components.
Assess Critical to Quality (CTQ) parameters and perform risk assessments to support product quality, process predictability, and decision-making.
Apply statistical tools and data analysis techniques to identify root causes, resolve quality issues, and implement effective corrective actions.
Initiate and support Corrective and Preventive Actions (CAPAs), including leading investigations and corrective action activities when required.
Support process control initiatives and promote consistent manufacturing practices across operations.
Identify and recommend continuous improvement opportunities to enhance product quality, operational efficiency, and compliance.
Manage day-to-day Quality Management (QM) Engineering activities for assigned products and operational projects.
Partner with manufacturing, engineering, and cross-functional teams to support product launches, process improvements, and quality initiatives.
Ensure consistent implementation and application of Quality Systems for both new and existing product lines.
Maintain compliance with FDA regulations, ISO standards, and other applicable quality and regulatory requirements.
Support quality-related activities including change controls, product quality notifications, post-market activities, IVDR compliance, and customer complaint investigations.
Utilize enterprise systems and quality tools to drive compliance, documentation accuracy, and process efficiency.
Serve as a subject matter expert (SME) during internal and external audits, as needed.
Foster collaborative and inclusive working relationships across departments that support Media manufacturing operations.

Required Qualifications

Bachelor's degree in Biological Sciences, Chemistry, or other related science field.
2 years experience in Quality or Engineering.

Preferred Qualifications

Experience in technical writing and executing process/test method validations.
Experience in a medical device or pharmaceutical manufacturing facility.

Knowledge and Skills

Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485 and 14971.
Ability and skill to effectively manage multiple tasks and drive execution of change management plans.
Ability and skill to lead or manage process control, supplier quality, and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC, Six sigma, additionally root cause analysis and project management techniques are routinely employed.
Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.
Knowledge of automated systems for filling and packaging are a plus.

Requirements

Bachelor's degree in Biological Sciences, Chemistry, or other related science field.
2 years experience in Quality or Engineering.
Experience in technical writing and executing process/test method validations.
Experience in a medical device or pharmaceutical manufacturing facility.
Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485 and 14971.
Ability and skill to effectively manage multiple tasks and drive execution of change management plans.
Ability and skill to lead or manage process control, supplier quality, and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC, Six sigma, additionally root cause analysis and project management techniques are routinely employed.
Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.
Knowledge of automated systems for filling and packaging are a plus.

Benefits

401(k) Matching
Medical, Dental & Vision
Unlimited PTO

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.