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ARCH · 1 day ago

Quality Engineer {SE}

Emerson, NJ

Full-time

Onsite

Mid Level

4+ years exp

ARCH Global Precision is a company focused on precision manufacturing, and they are seeking a Quality Engineer to manage regulatory submissions and ensure compliance with quality standards. The role involves collaborating with cross-functional teams, providing regulatory advice, and conducting audits to maintain quality goals.

FinanceManufacturing

Growth Opportunities

Responsibilities

Collect documentation and coordinate with cross-functional teams to prepare regulatory submissions to regulatory agencies

Create and maintain regulatory submission timelines and track deliverables to ensure company goals are met

Provide strategic input and regulatory advice to project teams and development programs including new product development and changes to existing products

Keep abreast of current regulatory landscape for medical devices globally, g. FDA guidance documents, EU MDR, EU guidance documents, etc

Develop and communicate recommendations regarding new/emerging regulations to management and project teams

Represent the company and work directly with regulatory authorities on regulatory issues and submissions

Provide in-house training on quality/regulatory related issues

Support international RA and QA efforts and collaborate with other teams across the company as needed

Review quality system processes to improve awareness, visibility and communication on quality initiatives to support assigned quality goals and objectives

Conduct onsite audits and host regulatory agency audits as needed

Evaluate, author and review SOPs, Forms, Work Instructions

Handle customer related quality issues

Prioritize daily tasks resulting in “on-time“ processing

Establish and maintain an import and export compliance program

Assist Shipping/Receiving/Warehouse/Repairs personnel

Recommend measures to motivate employees to improve operation methods, equipment performance, product quality or efficiency

Perform physical inventory checks with Purchasing

Observe and monitor gauges, dials and other indicators to ensure that operators conform to SOPs

Perform all aspects of building management including safety and sanitation regulations

Maintain commitment to Quality Goals and Quality Policy

Complete jobs and tasks as assigned

Qualification

ISO 13485 CertificateAudit ExperienceMedical Device ExperienceQMS SystemsMicrosoft OfficeStaff supervisionExport/Import experienceOrganizational skillsCommunication skillsDetail-oriented