Senior QA Validation & Verification Specialist

Goods & Services; Valle de Chalco Solidaridad; A distancia; USD 60,000 - 100,000; Jornada completa

Descripción de la vacante

An innovative design and technology company is seeking a Senior Specialist Software QA to enhance quality systems in the medical device industry. This role involves ensuring compliance with FDA and ISO regulations through effective software validation processes. You will lead initiatives to improve software quality and manage risk while collaborating with various teams to deliver high-quality products. Join a forward-thinking organization that values creativity, service, and craftsmanship, and be part of a mission-driven team that strives to make a positive impact on the world.

Servicios

Remote Work

Laptop and Headset Provided

Full Time Job

Professional Development

Internal Referral Program

External Referral Program

Formación

• 5+ years’ experience in Quality Assurance in the Medical Device Industry.
• Knowledge of FDA regulations and software validation requirements.
• Experience in software testing practices and methodologies.

Responsabilidades

• Complete SQA tasks in compliance with Quality System Requirements.
• Lead software remediation and risk management initiatives.
• Develop and maintain Standard Operating Procedures for compliance.

Conocimientos

Quality Assurance

Software Testing

Regulatory Affairs

Analytical Skills

Communication Skills

Educación

BS in Engineering

BS in Chemistry

BS in Biotechnology

BS in Life Science

Herramientas

GAMP 5

ISO Lead Auditor

FDA QSR

Descripción del empleo

About Goods & Services
We are a global design and technology company; we make things better by making better things.

Our DNA:

Purpose/ Put people first.
Vision/ Help the world’s most ambitious brands and people design better futures.
Mission/ Add value by creating experiences people love.
Values/ Service is our hallmark, creativity our spark, and craftmanship our passion.
Spirit/ Make things better by making better things.

Let’s break it down
Goods & Services is looking for a Senior Specialist Software QA who supports the development, implementation, improvement, and/or effectiveness of quality systems in compliance with applicable company, FDA, ISO, and other regulatory agency regulations, policies, and standards through implementation of effective software validation and change control processes.

What you’ll do:

• Complete Software Quality Assurance (SQA) tasks in accordance with current Quality System Requirements.
• Subject matter expert for the non-product software lifecycle. Review and assess software activities (suppler evaluations, validation, lifecycle deliverable documents) to ensure compliance with applicable procedures, standards and regulatory requirements.
• Lead software remediation and risk management initiatives.
• Work independently according to established objectives. Can plan and coordinate own work according to higher-level project schedules.
• Define validation documentation requirements within the established Software Development Life Cycle (SDLC). Review and approve software lifecycle deliverables. Provide accuracy, clarity, consistency, completeness, and compliance for multiple projects. Deliverables include System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices, and Verification/Validation Summary Reports for assigned projects.
• Report unexpected events, issues, or software bugs which occur during verification/validation to project team and management and according to established quality processes.
• Develop, maintain, review, and approve Standard Operating Procedures (SOPs), as necessary to ensure compliance to relevant FDAQSR, ISO guidelines, including 21 CFR Part 11 and corporate requirements as they relate to the development, verification, validation, and maintenance of computerized systems used in the Quality System as well as those used in development of software/firmware products.
• Responsible for implementation and maintenance of assigned software Validation Master Plan(s).
• Communicate laws/regulations, standards, and guidance documents pertaining to software in the medical device industry, with awareness of patient risk, and legal and financial ramifications to customers, the business, and business partners.
• Perform other duties and projects as assigned, with relation to compliance and Quality Systems.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships.

What you’ll need:

• BS in Engineering, Chemistry, Biotechnology, Life Science, or related technical field.
• 5+ years’ experience in Quality Assurance Regulatory Affairs role in the Medical Device Industry.
• Knowledge of laws/regulations, standards, and guidance documents pertaining to the medical device industry (i.e. 13485, MDSAP, IVDR, FDA QSR, 14971). In particular, 21 CFR Part 11 and software validation requirements.
• Experience in software testing practices, methodologies and techniques, preferably in testing Non-Product Software in Medical Device or other regulated industry.
• Medical device or regulated industry experience in qualification of computerized/software systems according to accepted industry framework such as GAMP 5, ICH, or ASTM guidelines and principals.

Nice to have:

• Qualified Auditor certification or comparable certification (i.e. CQA, CBA, ISO Lead Auditor). Experience performing software Supplier/Vendor qualification assessment and audits.
• ASQ Certification or equivalent certification in software quality assurance or software validation.
• Experience with embedded or product software and/or Cybersecurity.
• Solid analytical, written, and verbal communicationskills and the ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds.

Why you’ll love working here

We believe in making things better by making better things.

• Remote work: We’re a global design and technology company with presence in Mexico, US, and London.
• Tools: We provide you a laptop and headset, ready to add value with us!
• Full Time Job: Work from Monday through Friday.
• Be Rich Program: We live our mission by adding value to the communities.
• Professional Development: We offer regular in-house Centers of Excellence (CoE) and Learning Sessions for professional growth.
• Internal Referral Program: Refer a friend and if hired, participate in a raffle to win amazing prizes!

External Referral Program

If this position is not the right fit for you, refer someone and if hired, receive a $100 USD AMAZON gift card per hire.

• Send your referral via email to [e-mail]
• We will send a confirmation email.
• Receive your Amazon gift card if your referral is hired.

For more information: http://www.goodsandservices.com