Quality Engineer I

Key Responsibilities

• Supports and executes compliance activities related to the FDA Quality Management System Regulation (QMSR) (21 CFR Part 820), ISO 13485, EU MDR 2017/745, Design Controls, Validation/Qualification activities, and Corrective and Preventive Action (CAPA) processes.
• Owns assigned quality system investigations, including complaints, Nonconforming Material Reports (NCMRs), CAPAs, audit responses, and failure investigations.
• Ensures compliance with Department and Business Unit procedures and supports adherence to applicable quality system requirements.
• Owns and executes assigned quality engineering deliverables.
• Administers the Environmental Monitoring Program, including monitoring, data review, trending, investigation support, and documentation.
• Performs calibration-related activities and reviews associated documentation.
• Creates, reviews, and maintains Quality System Documents, Product Documents, and documents for the Design History File (DHF).
• Develops and executes protocols, validation activities, equipment qualifications, and test methods with guidance.
• Develops and maintains risk assessments, including Failure Modes and Effects Analysis (FMEA) and/or Fault Tree Analysis (FTA) with guidance.
• Participates in Internal and Supplier Quality System Audits and owns assigned audit-related actions.
• Supports Design Transfer activities, equipment introductions, and manufacturing process improvements.
• Manages assigned continuous improvement initiatives and quality improvement projects.
• 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.
• Performs general quality control and quality assurance activities.
• Conducts product and raw material testing and release.

Requirements & Tech Stack

• Microsoft applications (Word, Excel, Visio, presentation software)
• Minitab or equivalent software
• Familiarity with regulatory and statutory agencies (FDA, Notified Bodies)
• Familiarity with Lean and Six Sigma methodologies
• Proficiency in mathematics
• Basic applied statistics knowledge

Qualifications

• 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.
• 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.
• Ability to represent the Company and Business Unit in a professional manner.

Preferred Qualifications

• 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.
• 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.
• Ability to work effectively in a team-oriented, fast-paced environment.
• Occasional travel may be required based on business needs.