Quality Assurance Engineer- (Senior)

TechDigital Group; West Sacramento (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Development QA professional to ensure compliance and quality in software product development. This role involves collaborating with cross-functional teams to maintain an auditable Design History File, ensuring that all design processes meet regulatory standards. The ideal candidate will have a strong background in engineering or science, with experience in Design Assurance within regulated industries. Join a dynamic team where your expertise will contribute to the success of innovative products that meet high-quality standards and regulatory requirements.

Qualifications

• 5+ years of relevant experience in engineering, technology, or science.
• Experience in Design Assurance supporting software/hardware projects.

Responsibilities

• Fulfill the Development QA role on Software Product Development teams.
• Ensure compliance with regulatory agency requirements and company policies.

Skills

Agile Development

Leadership Skills

Communication Skills

Education

BS degree in engineering, technology, or science

Master's degree

Doctoral degree

Job description

Description/Comment:

1. Fulfill the Development QA / Design Assurance role on Software Product Development Core and/or Design Change Teams as the design progresses through the development lifecycle.
2. Collaborate with cross functional teams to ensure that the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs.
3. Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.
4. Work cross functionally on defining performance requirements, conducting risk analysis, reviewing verification and validation test plans, execution, and data to complete the design transfers.

QUALIFICATIONS:

1. BS degree in engineering, technology, or science from an accredited college or university with 5+ years relevant experience OR
2. Master's degree in field with 3+ years experience OR
3. Doctoral degree in field with 0-2 years experience

PREFERRED QUALIFICATIONS:

1. Agile Development experience
2. Experience in Design Assurance (QA) supporting software/hardware development projects in Quality Systems (Design Control) and Quality Design Assurance (DHF Compliance)
3. Experience in medical device or other regulated industries
4. Effective leadership and interpersonal skills
5. Good written and verbal communication skills