Quality Engineer I

Job Title

We are the people who give possibilities purpose

BD 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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Essential / Key Job Responsibilities:

• Supports and executes compliance activities related to the Food and Drug Administration (FDA) Quality Management System Regulation (QMSR) (21 CFR Part 820), International Organization for Standardization (ISO) 13485, European Union Medical Device Regulation (EU MDR 2017/745), Design Controls, Validation/Qualification activities, and Corrective and Preventive Action (CAPA) processes through implementation and monitoring of quality system procedures.
• Owns assigned quality system investigations and associated actions, including complaints, Nonconforming Material Reports (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 Failure Modes and Effects Analysis (FMEA) and/or Fault Tree Analysis (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 but Not Limited To:
• General quality control and quality assurance activities.
• Product and raw material testing and release.
• Performs other duties as assigned.

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, Corrective and Preventive Action (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.

Physical Demands:

• Ability to sit, stand, walk, bend, reach, and perform routine office, laboratory, and manufacturing-related activities.
• Ability to use standard office equipment, including computers and communication devices.
• Ability to occasionally lift and carry materials consistent with normal business operations.
• Ability to work in manufacturing and laboratory environments, as required.
• Ability to work in areas containing radioactive materials, as applicable.

Work Environment:

• Work is performed in office, laboratory, and manufacturing environments.
• Work may be performed in an open-cubicle office environment.
• Exposure to manufacturing and laboratory activities may be required.
• Use of personal protective equipment (PPE) may be required in designated areas.
• Candidates must be able to work effectively in a team-oriented, fast-paced environment.
• Occasional travel may be required based on business needs.

Disclaimer:

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended to be inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.