Quality Assurance Engineer @Altoida, Inc.

Salary -	Remote Location 🇺🇸 USA Only
Job Type Full-time	Posted 1mth ago

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[Hiring] Quality Assurance Engineer @Altoida, Inc.

Jul 24, 2024 - Altoida, Inc. is hiring a remote Quality Assurance Engineer. 📍Location: USA.

Position Overview

The Quality Assurance Engineer (QAE) will lead the implementation, continuous improvement and maintenance of the Quality Management System for a Software as a Medical Device product to meet the requirements of the FDA's Quality System Regulation, ISO 13485 and other software standards and Regulatory requirements as required. Partner with Product Development and other functional areas during the product development lifecycle to bring a product to market and continue to provide support once product is commercially available.

Essential Job Functions

Implement, maintain and continuously improve Quality Management System processes.

Maximize the quality of the processes and the products these produce, while driving corrective action and continuous improvement efforts.

Work with cross functional teams and Customers to achieve quality and regulatory compliance goals in projects and during the software development lifecycle.

Coach project teams and process owners, distributing quality metrics throughout the software lifecycle contributing to business and technical risk management, as well as preparing for external audits and inspections from customers and regulatory authorities, if required

Improve and maintain processes for Document Control, CAPA, Nonconforming Material, Training and Complaints.

Lead the organization in the development and use of the Risk Management Plan, FMEA and overall process development and execution.

Implement, maintain and continuously improve the process by which to create and control Design Control documentation, such as DHFs and DMRs.

Lead and manage the Internal Audit and Supplier Management processes

Requirements

Minimum of 5 years of directly related work experience in Quality Assurance within the medical device, medical device software and/or biotechnology industries.

Software quality experience is a plus.

Working knowledge of the FDA’s QSR, ISO 13485, ISO 14971, IEC 62304 and other applicable software standards.

Proven experience in quality management of software products preferred. Understand the software development and software product lifecycle phases

Bachelor’s Degree preferably in a Science or an Engineering or related technical discipline.

ASQ Certifications or equivalent a plus - CQA, CQE, CMQ/OE, CSQE

Other Skills/Abilities

Microsoft Windows and/or Apple Operating Systems

Microsoft Office tools – Word, Excel, PowerPoint

Confluence, Jira

Greenlight Guru

Software Quality Assurance experience in Medical Device testing a plus.

Quality Engineering experience in a Software only Medical Device a plus.

About The Company

Altoida, Inc.

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Before You Apply

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Back to Remote jobs > QA

Quality Assurance Engineer @Altoida, Inc.

Salary -	Remote Location 🇺🇸 USA Only
Job Type Full-time	Posted 1mth ago

🙈 Does this job need an edit?

Apply for this position Unlock 33,818 Remote Jobs

️

	Interview prep with FAANG+ mentors for $300K+ Software roles at top companies. Join free webinar.
🇺🇸	Be aware of the location restriction for this remote position: USA Only
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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