Regulatory Quality Engineer

Arch-Medical-Solutions; Kenosha (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Arch-Medical-Solutions is seeking a Quality System Management Representative to oversee the quality system at Elmhurst, IL and Kenosha, WI facilities. You will promote regulatory awareness, train staff on QMS standards, and drive compliance with FDA QSR, ISO 13485, and related regulations.

The role includes leading CAPA and MRB activities, coordinating audits, and managing process validation with internal and external stakeholders.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering or equivalent.
• 5–10 years of experience in medical device manufacturing quality engineering.
• Knowledge of ISO 13485 Quality Management System and FDA 21 CFR 820 Regulations.
• Familiarity with Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5M.
• Experience with design verification and validation and regulatory training.

Responsibilities

• Act as Quality System Management Representative for Elmhurst (IL) and Kenosha (WI) facilities.
• Promote awareness of regulatory and quality management system requirements; assist training on QMS and regulatory standards.
• Establish, implement, and maintain processes for the quality management system.
• Ensure compliance with FDA QSR, GMP, GDP, ISO 13485 and other applicable regulations.
• Lead or participate in development, implementation, and maintenance of standards and procedures (FDA, ISO 13485:2016, etc.).
• Act as a direct contact for FDA; ensure FDA registrations and device listings are current.
• Support ECO, CAPA, MRB and other QMS processes; create metrics to monitor process performance.
• Coordinate manufacturing process validation and maintain master validation program with stakeholders.
• Organize investigations and drive root-cause determinations and corrective action effectiveness.

Skills

Regulatory knowledge

QA Audits

Training

GMP basics

ISO 13485

Education

Bachelor's degree in mechanical or biomedical engineering

5–10 years medical device quality experience

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.

Qualifications

Skills

Behaviors

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Motivations

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Education

Experience

Licenses & Certifications

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.