Principal Software QA Engineer

Principal Software QA Engineer

Requirements

• Bachelor’s degree plus a minimum of 12 years related experience or Master’s Degree plus a minimum of 9 years related experience or waiver based on experience.
• Additional experience working in or knowledge of software platforms and applications, project design, validation, quality plans and risk management (including human factors engineering).
• Solid knowledge and experience working with medical device international regulations and related standards (ISO 13485, ISO 14971, ISO 62304, etc.).
• Language: English, Spanish (desirable).

Responsibilities

• Participates in the generation and review of Design History File and Risk Management documents throughout the product lifecycle.
• Advises and directs teams regarding compliance to procedures, standards and regulations.
• Ensures product quality meets requirements, and documentation is complete prior to approval.
• Participates on core teams supporting new product development or design changes.
• Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS.
• Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
• On projects of significant scope, leads the successful implementation of Design Control and Product Realization requirements for design, production and distribution of Werfen products.
• On new product development and or product performance investigations, provides guidance on most appropriate tools and techniques available.
• Provides input on product requirements, acceptance criteria, traceability, product evaluation, failure investigation and complaint analysis.
• Provides guidance on compliance of software to procedures and standards including cyber security and privacy requirements.
• Works with Solution Leader, Development, Testing, Marketing, Regulatory, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA).
• May supervise the work of others.
• Leads cross-functional projects on technical and quality issues.
• Identifies compliance gaps and suggest appropriate corrective actions as needed.
• Supports internal and external audits.
• Leads quality system improvement projects as required.

Preferred Qualifications

• Language: Spanish (desirable).
• Membership on external standards organizations of industry groups with influence of our products-desirable.