Software QA Engineer II

Design Quality Engineer | San Diego, CA (Hybrid)
We are seeking a talented and experienced Design Quality Engineer with a focus on software-related projects within the medical device industry. The ideal candidate will have a strong background in risk management and design controls, with a particular emphasis on software development processes. If this sounds like you, apply today!

Who you are:

• 3-5 years of experience in Quality Engineering roles within the medical device industry, with a focus on software development.
• In-depth knowledge of risk management principles and methodologies, with experience applying them to software systems.
• Familiarity with design control processes and regulatory requirements for medical devices, including ISO 13485, ISO 14971, and FDA regulations.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.

What you’ll do:

• Lead and facilitate risk management activities throughout the software development lifecycle, including hazard analysis, risk assessment, and mitigation strategies.
• Collaborate with cross-functional teams to develop risk management plans and ensure compliance with regulatory requirements.
• Implement and maintain design control processes for software-related projects, ensuring adherence to regulatory standards such as ISO and FDA regulations.
• Work closely with software engineers, product managers, and regulatory affairs professionals to align quality objectives with product development goals.
• Act as a subject matter expert on quality and regulatory matters related to software development, providing guidance on interpretation and application of standards and regulations.

What To Do Now:

Please send your resume to tmontello@provenrecruiting.com if you believe this opportunity is worth exploring and you match the criteria listed.

We support and promote people of various backgrounds, from race, religion and gender to geographical area, university, lifestyle and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Do not hesitate to apply now!

What does this position pay?
Compensation is determined by several factors which may include skillset, experience level, and geographic location.

The expected range for this role is $40.00 to $50.00 per hour. Please note this range is an estimate and actual pay may vary based on qualifications and experience.

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