Job Responsibilities: In this role, you will manage and support a variety of projects within the Quality Engineering department. Key responsibilities include:
Leading multiple quality-related projects, including:
Investigating customer complaints for medical devices.
Analyzing manufacturing processes and data.
Implementing corrective and preventive actions.
Driving continuous improvement in product quality and compliance.
Ensuring compliance with applicable quality standards and regulatory requirements for medical devices.
Collaborating with cross-functional teams and stakeholders to ensure project success.
Essential Duties and Job Functions:
Perform thorough investigations of customer complaints, providing detailed analysis of processes and data.
Execute complaint investigations using a multifunctional approach, addressing issues systematically.
Oversee all phases of complaints requiring investigation, ensuring timely completion.
Collaborate closely with investigation owners to resolve issues and address overdue cases.
Verify that complaint investigations are adequate and comply with applicable procedures.
Apply quality engineering principles to ensure regulatory compliance and optimize product development, manufacturing, and distribution processes.
Investigate moderately complex manufacturing quality and compliance issues for all production processes.
Optimize manufacturing processes using engineering methods like Six Sigma and Lean.
Develop and maintain technical content of risk management files.
Create training and documentation materials for production processes.
Assign and coordinate tasks for technicians, providing guidance and feedback.
Knowledge & Skills:
Strong documentation, communication, and interpersonal skills.
Basic understanding of statistical techniques.
Experience working with laboratory/industrial equipment.
Solid understanding of engineering principles, theories, and concepts.
Strong problem-solving, organizational, analytical, and critical thinking skills.
Thorough understanding of processes and equipment used in assigned work.
Knowledge of and adherence to quality systems.
Meticulous attention to detail.
Ability to interact professionally with all organizational levels.
Capability to manage competing priorities in a fast-paced environment.
Proficiency in teamwork, including vendor and stakeholder management.
Ability to build productive internal/external working relationships.
Adherence to all company rules and requirements (e.g., safety protocols).
Proficiency with computer applications and software related to engineering, such as CAD.
Education & Experience:
Bachelor's degree in Engineering.
0-2 years of relevant experience.
Experience in medical device industry preferred.
Familiarity with quality systems and regulatory requirements for medical devices is highly desirable.
Certification in quality engineering or related field is a plus.