Regulatory Quality Engineer

About the role

Acts as a Quality System Management Representative for the Elmhurst (IL) and Kenosha (WI) facilities, ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

Responsibilities

• Assists in training personnel on all aspects of the Quality System and regulatory standards
• Ensures that processes needed for the quality management system are established, implemented, and maintained
• Complies with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation - 21 CFR 820, GMP guidelines, GDP, ISO 13485, ISO and other applicable regulatory requirements
• Leads and/or participates in the development, implementation, compliance, and maintenance of standards and procedures
• Acts as a direct contact for FDA and ensures FDA registrations and device listings are current
• Participates and supports the ECO, CAPA, MRB and other Quality System processes
• Creates metrics that drive effective monitoring of processes, value-add improvements and communication at all levels of the organization
• Develops and implements process flows in cooperation with functional groups
• Ensures risk assessment activities are executed and maintained according to regulatory standards
• Organizes investigation activities and coordinates appropriate resources to drive for root cause determinations, correction action implementation and effectiveness verification
• Leads vendor, internal/external, and process audits at both facilities and provides necessary documentation
• Performs validation training and establishes and maintains master validation program
• Designs and oversees training program(s), including ISO internal training
• Responsible for internal and external audits and interferes with suppliers to resolve quality issues
• Coordinates manufacturing process validation requirements, documentation and maintenance of validated processes with internal and external stakeholders

Qualifications

• Bachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering is strongly preferred or equivalent
• Five to ten years of experience in medical device manufacturing industry and in the quality engineering role, and/or training
• Equivalent combination of education and experience
• Knowledge of the medical device manufacturing industry
• Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations
• Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M
• Familiarity with test methods and standards for the design, verification, and validation of medical device products is required