Regulatory Quality Engineer
About this role
- 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.
Company at a glance
American Manufacturing, Serving the World
We are driven by precision. Our engineering expertise and precision-machining capabilities serve the medical, aerospace and defense, and industrial markets. We offer a synergy of resources to reduce your manufacturing costs, optimize the performance of your components and products, and cut your supply chain risks.
ARCH has multiple state-of-the-art facilities that manufacture high-quality cutting tools, precision-machined components, and products. Working with ARCH, your business gains the advantage of an expanding range of cutting-edge resources for all your precision-machining needs. Our facilities are strategically located across the U.S. to optimize your outsourced precision-machining needs.
We strive to be your trusted and proactive partner. ARCH is structured to provide the capacity, flexibility, and scalability you need to succeed. We offer design-for-manufacturability, prototyping, on-site application testing, program management, technical support, and customized services.
The rise of American manufacturing requires the support of highly evolved and collaborative precision-machining partners. Our comprehensive experience in critical part production across a broad range of applications allows us to provide a dynamic range of solutions.
We truly understand the critical nature of the components and products we work with and are intently focused on delivering exacting quality to our customers, and ultimately to their customers. We combine leading-edge expertise and industry standards to ensure consistent quality at every step.
To maintain our leading edge, we invest in the continuous improvement of our manufacturing and quality assurance processes. The sharing of knowledge, technologies, and best practices across our teams strengthens our competitive advantage, accounting for performance breakthroughs, value creation, and cost containment.
Tired of cold applications?
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Know someone who'd be great for this?