Medical Software, Sr. Quality Assurance Engineer

Job description

DESCRIPTION

Amazon strives to be earth’s most customer-centric company, where customers always receive high quality products with innovative and advanced features and capabilities. Envision working with energetic colleagues and inspirational leaders. Grow your career with the world class company who is looking to hire Quality Engineer to help expand their Medical device design and development process. Amazon Lab126 is an inventive research and development company that designs and engineers high-profile consumer electronics. Lab126 began in 2004 as a subsidiary of Amazon.com, Inc., originally creating the best-selling Kindle family of products. Since then, we have produced groundbreaking devices like Fire tablets, Fire TV and Amazon Echo.

The Medical Software, Senior Quality Assurance Engineer (Sr. QAE) is accountable for quality and quality risk management activities for Class I and Class II medical devices, with a focus on Software Medical Devices. The Medical Software, Senior QAE supports the company’s quality system activities in compliance with the FDA’s Quality System Regulation, and in accordance with FDA 820 Title 21 and as well as ISO 13485 and ISO14971 requirements.

Successful candidates for this role will have demonstrated sound working knowledge of Software based Medical Devices, Quality Management Systems, and good understanding of the entire software lifecycle management in a medical environment.

The role has strategic, programmatic, and operational responsibilities in support of the broader Supply Chain & Compliance organization. In relation to Quality Management Systems (QMS) this role supports the Sr Manager of QMS with the ongoing operation and improvement of the QMS for the supply chain organization. In relation to QMS strategy, this role supports supply chain & compliance leadership team to develop and implement new processes, initiate and implement strategic initiatives, drive operational efficiencies, and effective organizational communication. The candidate should possess persuasive and outstanding communication skills, and be effective in working across functional boundaries.

As part of the organization’s QMS leadership team, candidate will participate in the continuous improvement of Amazon Devices, Operations and Supply Chain’s QMS. Candidate will be responsible for the development and management of the supply chain’s QMS and its alignment with the overall organization’s QMS. Responsibilities include authoring QMS procedures and processes, analyzing current and future procedural needs, providing training on the QMS, and performing internal reviews across supply chain to ensure consistent QMS implementation. Work will involve ownership of many phases or sub-tasks of projects or entire projects of moderate complexity as well as supporting supply chain departments in preparation for any internal or external QMS audits

The candidate will have the following responsibilities:

· Primary point of contact for all quality management activities related software based medical offerings managed by the Amazon Devices team, interfacing with many internal departments, and external suppliers.
· Provides guidance for design controls, risk management, and decisions on product development activities product development, to ensure compliance with quality goals, procedures, and applicable regulations
· Responsible for quality systems support for software based medical devices.
· Support existing processes, and mechanisms, such as document control, training, CAPAs, Quality metrics, Software verification & Validation.
· Responsible for driving continual process improvements, using data, and analytics to identify opportunities for improvement and working with management, and team members to successfully address these opportunities
· Perform and document internal audits and make recommendations for corrective actions
· New Product Introduction (NPI), Sustaining activities and Supplier Process Validations
· You will be the expert responsible for providing guidance on software test and equipment validation strategies.
· Review and approve changes made to product and processes and validation/qualification protocols and reports.
· Work with internal customers and suppliers to ensure that process validation related non-conformances, failure analysis reports and deviations are appropriately investigated, documented, reviewed and approved.
· Develop and implement quality workflows. Responsible for drafting and/or updating quality procedures for quality operations functions.
· Be a subject matter expert, communicating, and educating the broader devices team on FDA Compliance requirements
· Co-ordinate Management review process and ensure that it happens according to the internal plan.
· Conduct benchmarking studies to determine best practices/designs and future trends
· Exhibit a constant passion for delivering an exceptional customer experience
· Travel as required to accomplish business needs

PREFERRED QUALIFICATIONS

· 15+ years experience in operations or supply chain
· MBA and/or advanced degree in a technical or business discipline
· Six Sigma Certification
· Experience of Kaizen principles SCRUM Methodology (or equivalent) and Lean/Six Sigma principles experience
· Master’s in Business, Operations Management, System Analysis/Computer Science or related field

Lab126 is part of the Amazon.com, Inc. group of companies and is an Equal Opportunity-Affirmative Action Employer – Minority/Female/Disability/Veteran/Gender Identity/Sexual Orientation

Desired profile

BASIC QUALIFICATIONS

· 6+ year of experience working as a Quality Assurance Engineer
· Experience in manual testing
· Experience in automation testing
· Bachelor’s degree Business, Operations Management, System Analysis/Computer Science or related field
· 10+ years of experience in operations, throughout the product life cycle from concept to EOL.
· 3+ years of conducting Internal Quality Audits, writing Audit Reports and verifying effectiveness of the Corrective Actions
· Experienced in conducting Supplier Audits across a variety of industry sectors
· Experience leading and influencing cross functional teams
· Experience in risk management disciplines, must be able to apply quality principles
· Strong written and verbal communications skills
· Strong organization skills
· Ability to work independently and collaboratively
· Ability to prioritize and manage to critical project timelines in a fast-paced environment.
· Direct experience with software medical devices in a regulatory environment