The Quality Engineer will play a key role in supporting the medical device manufacturing process by applying Quality Engineering principles to ensure compliance with regulatory standards and maintaining product quality. This role will focus on sustaining engineering efforts, process control, validation, and continuous improvement to align with Embecta's high standards of quality.

• Provide technical expertise for product initiatives within the plant, determining resource needs and supporting the quality aspects of projects.
• Lead root cause analysis, FMEAs, risk mitigation strategies, and other quality engineering tools to support projects.
• Develop and implement validation protocols and reports, ensuring compliance with established procedures.
• Utilize Lean and Six Sigma methodologies, statistical analysis tools (e.g., Minitab), and DOE techniques to support continuous improvement projects.
• Establish strong working relationships across operational teams to monitor and analyze process controls, environmental conditions, and customer complaints.
• Ensure alignment with corporate and regulatory standards (21 CFR 820, ISO 13485) and update quality assurance procedures as needed.
• Support the Quality Engineering and Quality Systems groups by contributing to validation efforts and cross-functional projects.
• Demonstrate working knowledge of applicable regulatory requirements and participate in new product development and sustaining engineering projects.

• Quality Engineering Principles: Solid understanding of quality engineering techniques, including root cause analysis, FMEAs, and risk mitigation.
• Validation and Process Improvement: Hands-on experience with validation processes, Lean and Six Sigma methodologies, and design of experiments (DOE).
• Statistical Analysis: Proficiency in statistical analysis software (Minitab or similar) for problem-solving and data-driven decision-making.
• Regulatory Knowledge: Familiarity with medical device regulations, particularly 21 CFR 820 and ISO 13485.
• Collaboration: Strong interpersonal skills for working effectively with cross-functional teams.
• Manufacturing Experience: Prior experience in a manufacturing environment, particularly in medical devices.

• Bachelor's Degree: Required, preferably in Engineering (Industrial, Mechanical).
• Six Sigma Certification: ASQ Certified Quality Engineer (CQE) preferred.

• 3+ years of Quality Engineering experience in a regulated environment, particularly with validation, failure analysis, and quality management systems.