Regulatory Quality Engineer

ARCH; Kenosha (WI); On-site; USD 95,000 - 130,000; Full time

Job summary

ARCH is seeking a Quality System Management Representative for the Elmhurst, IL and Kenosha, WI facilities to promote regulatory and quality system compliance. The role requires training personnel on the Quality System and regulatory standards, and ensuring processes are established, implemented, and maintained.

Responsibilities include leading audits, CAPA, ECO, and MRB activities, developing metrics, and coordinating risk assessments and validation programs under FDA QSR 820 and ISO 13485.

Qualifications

• Strong knowledge of medical device quality management systems.
• Experience training personnel on quality standards and regulatory requirements.
• Familiarity with CAPA, ECO, MRB and internal audits.

Responsibilities

• Act as Quality System Management Representative for Elmhurst, IL and Kenosha, WI facilities.
• Promote awareness of regulatory requirements and quality system requirements across the organization; train personnel.
• Establish, implement and maintain processes for the quality management system.
• Lead or participate in supplier, internal and process audits; ensure documentation and records are current.

Skills

Quality Systems

Regulatory Compliance

FDA QSR 820

ISO 13485

Auditing & CAPA

Education

Bachelor's degree in mechanical or biomedical engineering

Tools

Geometric Dimensioning & Tolerancing (GD&T)

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.

• 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 participants 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.