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

Essential / Key Job Responsibilities

Supports and executes compliance activities related to FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR 2017/745, Design Controls, Validation/Qualification activities, and CAPA processes through implementation and monitoring of quality system procedures.
Owns assigned quality system investigations and associated actions, including complaints, NCMRs, CAPAs, audit responses, and failure investigations, and drives activities through completion.
Ensures compliance with Department and Business Unit procedures and supports adherence to applicable quality system requirements.
Owns and executes assigned quality engineering deliverables in support of Project Team and Quality Department objectives.
Administers the Environmental Monitoring Program, including monitoring activities, data review, trending, investigation support, and associated documentation.
Performs calibration-related activities and reviews associated documentation as required.
Creates, reviews, and maintains Quality System Documents, Product Documents, and documents required for the Design History File (DHF).
Develops and executes protocols, validation activities, equipment qualifications, and test methods with guidance, as required.
Develops and maintains risk assessments, including FMEA and/or FTA, with guidance as required.
Participates in Internal and Supplier Quality System Audits and owns assigned audit-related actions through completion.
Supports Design Transfer activities, equipment introductions, and manufacturing process improvements.
Manages assigned continuous improvement initiatives, quality improvement projects, and associated action plans, and drives activities through completion.
Maintains awareness of industry developments through training and quality-related professional development activities.
Maintains compliance with established corporate safety standards, quality system requirements, operating procedures, and applicable site policies.
Other duties as assigned, including general quality control and quality assurance activities, product and raw material testing and release.

Education and/or Experience - Required

Bachelor's degree in a scientific discipline (Engineering, Engineering Technology, Chemical, Biological, or equivalent).
Zero (0) to two (2) years of experience in the medical device, pharmaceutical, or other regulated industry.
Internship, co-op, academic, laboratory, or industry experience supporting quality, validation, manufacturing, engineering, or regulatory activities.
Demonstrated understanding of problem solving data analysis, investigations, and quality system concepts.

Education and/or Experience - Preferred

Experience supporting validation, CAPA, complaint investigation, quality system auditing, or related quality activities.
Experience supporting Environmental Monitoring, microbiological testing, or laboratory quality activities.
Experience working in a regulated manufacturing environment.
Experience with statistical techniques.

Required Qualifications

Proficiency in Microsoft applications including Word, Excel, Visio, presentation software, Minitab, or equivalent software.
Familiarity with regulatory and statutory agencies (FDA, Notified Bodies, etc.).
Familiarity with Lean and Six Sigma methodologies.
Ability to work effectively in a team environment.
Demonstrated organizational and time management skills.
Ability to manage multiple assignments and priorities.
Ability to interpret Regulations, Organizational, Business Unit, and Department procedures.
Strong oral and written communication skills in English.
Ability to effectively present information in one-on-one and group settings to supervisors, management, and other employees.
Ability to represent the Company and Business Unit in a professional manner.
Proficiency in mathematics.
Basic applied statistics knowledge.

Preferred Qualifications

Ability to translate quality requirements into product specifications.
Advanced statistics and/or Six Sigma Green Belt certification.
American Society for Quality (ASQ) certification.

Requirements

Bachelor's degree in a scientific discipline (Engineering, Engineering Technology, Chemical, Biological, or equivalent).
Zero (0) to two (2) years of experience in the medical device, pharmaceutical, or other regulated industry.
Internship, co-op, academic, laboratory, or industry experience supporting quality, validation, manufacturing, engineering, or regulatory activities.
Demonstrated understanding of problem solving data analysis, investigations, and quality system concepts.
Proficiency in Microsoft applications including Word, Excel, Visio, presentation software, Minitab, or equivalent software.
Familiarity with regulatory and statutory agencies (FDA, Notified Bodies, etc.).
Familiarity with Lean and Six Sigma methodologies.
Ability to work effectively in a team environment.
Demonstrated organizational and time management skills.
Ability to manage multiple assignments and priorities.
Ability to interpret Regulations, Organizational, Business Unit, and Department procedures.
Strong oral and written communication skills in English.
Ability to effectively present information in one-on-one and group settings to supervisors, management, and other employees.
Ability to represent the Company and Business Unit in a professional manner.
Proficiency in mathematics.
Basic applied statistics knowledge.

Benefits

Medical, Dental & Vision
Health Savings Account
Flexible Spending Account
Life & Disability Insurance
Wellness Resources
Mental Health Support
401(k)
Deferred Compensation
Financial Counseling
DailyPay
Paid Time Off
Company Holidays
Educational Assistance
Parental Leave
Adoption Assistance
Backup Care
Caregiving Support
Employee Assistance Programs
Commuter Benefits
Pet Insurance
Legal Services
Associate Discount Programs
Bereavement Leave
Military Leave
Personal Leave
Family and Medical Leave
Jury Duty Leave

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.