Quality Engineer I

Becton Dickinson Medical Devices•Carol Stream, IL

17d•Onsite

About The Position

The Quality Engineer I supports quality engineering and quality system activities in a regulated medical technology environment. The role supports compliance with FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR 2017/745, design controls, validation and qualification activities, and CAPA processes through implementation and monitoring of quality system procedures. The position owns assigned investigations and actions, including complaints, NCMRs, CAPAs, audit responses, and failure investigations, and drives them through completion. The role supports project team and Quality Department objectives by delivering assigned quality engineering work, administering the Environmental Monitoring Program, performing calibration-related activities, and creating and maintaining quality system, product, and Design History File documentation. With guidance as needed, the engineer develops and executes protocols, validations, equipment qualifications, test methods, and risk assessments. The position also participates in internal and supplier audits, supports design transfer and manufacturing improvements, and manages assigned continuous improvement projects. Work is performed in office, laboratory, and manufacturing environments, with possible exposure to laboratory and manufacturing activities and designated areas requiring PPE. Occasional travel may be required. The role requires effective teamwork in a fast-paced environment and compliance with corporate safety standards, quality requirements, procedures, and site policies.

Requirements

Bachelor's degree in a scientific discipline such as Engineering, Engineering Technology, Chemical, or Biological, or equivalent.
Zero to two years of experience in the medical device, pharmaceutical, or another 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, and Minitab or equivalent software.
Familiarity with regulatory and statutory agencies, including FDA and Notified Bodies.
Familiarity with Lean and Six Sigma methodologies.
Ability to work effectively in a team environment and manage multiple assignments and priorities.
Demonstrated organizational and time management skills.
Ability to interpret regulations and organizational, Business Unit, and Department procedures.
Strong oral and written communication skills in English and ability to present information to supervisors, management, and employees in individual and group settings.
Ability to represent the Company and Business Unit professionally.
Proficiency in mathematics and basic applied statistics knowledge.
Ability to sit, stand, walk, bend, reach, use standard office equipment, and occasionally lift and carry materials consistent with normal business operations.
Ability to work in office, laboratory, and manufacturing environments, including areas containing radioactive materials as applicable.

Nice To Haves

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

Responsibilities

Support and execute compliance activities related to FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR 2017/745, design controls, validation and qualification, and CAPA processes.
Own assigned quality system investigations and associated actions, including complaints, NCMRs, CAPAs, audit responses, and failure investigations, and drive them through completion.
Ensure compliance with Department and Business Unit procedures and applicable quality system requirements.
Execute assigned quality engineering deliverables in support of Project Team and Quality Department objectives.
Administer the Environmental Monitoring Program, including monitoring, data review, trending, investigation support, and documentation.
Perform calibration-related activities and review associated documentation as required.
Create, review, and maintain Quality System Documents, Product Documents, and Design History File documents.
Develop and execute protocols, validation activities, equipment qualifications, and test methods with guidance as required.
Develop and maintain risk assessments, including FMEA and/or FTA, with guidance as required.
Participate in Internal and Supplier Quality System Audits and own assigned audit-related actions through completion.
Support Design Transfer activities, equipment introductions, and manufacturing process improvements.
Manage assigned continuous improvement initiatives, quality improvement projects, and action plans through completion.
Maintain awareness of industry developments through training and quality-related professional development.
Comply with corporate safety standards, quality system requirements, operating procedures, and applicable site policies.
Perform general quality control and quality assurance activities, product and raw material testing and release, and other assigned duties.