Bachelor's degree in mechanical or biomedical engineering preferred or equivalent work experience.
5-10 years in medical device manufacturing and quality engineering roles.
Strong knowledge of ISO 13485 Quality Management System and FDA regulations (21CFR 820).
Familiar with Geometric Dimensioning and Tolerancing per ASME Y14.5M.
Experience with testing methods and standards for medical device design and validation.
Responsibilities
Act as Quality System Management Representative for facilities in Elmhurst (IL) and Kenosha (WI).
Promote regulatory awareness and provide training on quality systems across the organization.
Establish, implement, and maintain quality management system processes.
Serve as direct contact for FDA and maintain current registrations and device listings.
Lead audits and ensure compliance with standards like FDA and ISO 13485:2016.
Benefits
Comprehensive training programs including ISO standards.
Opportunities for career advancement within the quality system management.
Involvement in significant regulatory compliance responsibilities.
Access to advanced quality management methodologies and tools.
Full Job Description
Acts as a Quality System Management Representative for the Elmhurst (IL) and Kenosha (WI) facilities.
Ensures the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization. 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 (FDA, ISO 13485:2016, etc.) and procedures.
Acts as a direct contact for FDA. 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. Establishes and maintains master validation program, including site and individual products and process master validations.
Designs and oversees training program(s), including ISO internal training.
Responsible for internal and external audits.
Interferes with suppliers to resolve quality issues.
Coordinates manufacturing process validation requirements, documentation and maintenance of validated processes with internal and external stakeholders.
Other duties as assigned.
Qualifications
Bachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering is strongly preferred or equivalent,
or five to ten years of experience in medical device manufacturing industry and in the quality engineering role, and/or training,
or 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.
