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Design Quality Software Validation Engineer
4 months ago
Design Quality Software Validation Engineer - Hybrid
Location of Work Chula Vista, CA; San Diego, CA
Employment Type Full Time Employee
Job Description
Our mission
At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.
Our brand promise
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.
Remarkable service: A seamless, personal process designed around you and your needs.
Trusted performance: Our product family is the result of years of experience championing surgeons and listening to their expertise.
Outstanding value: No matter the surgical specialty, we deliver quality products for all markets.
Our people promise
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.
What you will do This is a hybrid role that is required to move in Tijuana, Mexico 3-4 days a week and 1-2 days remotely
Design, develop, and implement software validation test strategy, test plans, test automation scripts, and test procedures to meet requirements.
Coordinate all validation activities through constant communication with key stakeholders.
Be responsible for providing all documentation required to support assembly equipment. This includes but is not limited to operating instructions, electrical schematics, specifications, parameter settings, software backups etc.
Create and provide equipment specifications to vendors for quoting automated and manual equipment.
Support the development, implement various product, and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Design and conduct experiments for process optimization and/or improvement.
Follow and help develop best practices and standard procedures.
Act as a Quality liaison within project teams, guiding quality measures throughout the software development lifecycle and overseeing quality-related documentation.
Integrate quality practices into software development, scientific computation, and data acquisition processes.
Evaluate and approve software project deliverables, ensuring compliance with procedural standards.
Conduct risk assessments, manage risk mitigation activities, document product risks, and liaise with the risk management team for updates.
Maintain adherence to company's quality processes in software development and risk management efforts.
What you will need
Bachelors degree in engineering or equivalent education and experience
3+ years of experience with electrical/control design experience within medical device.
Proficient understanding of FDA and international regulations, including QSRs, ISO.
Over 2 years of experience in software Quality Assurance within the medical devices sector or other FDA-regulated industries, covering the full product lifecycle from conceptual design to market release.
Experience managing the Design Control process, including participation in design reviews and the maintenance of design history files.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Strong project management and leadership skills, including the demonstrated ability to lead project teams and resolve quality-related issues in a timely and effective manner.
Advanced computer skills, including statistical/data analysis and report writing skills.
Experience implementing various product and process improvement methodologies.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Fluent in Spanish and English required.
What we value
Customer First - We deliver extraordinary experiences.
Accountability - We do what we say.
Integrity - We do what is right.
Inspired - We love what we do.
One Global Team -We before me, always.
Join us today and Excel@Corza
Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.
Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.
