Senior Software Quality Engineer - MedTech, SD

Regulatory Jobs; San Diego (CA); On-site; USD 137,000 - 169,000; Full time

Benefits offered by this job

Total Rewards program

Competitive compensation

Job summary

BD is seeking a core team quality representative for design control projects, focusing on new product development and sustaining efforts in San Diego. You will manage quality planning, verification/validation, risk management, and regulatory support, ensuring traceability and conformance to QMS, working with cross-functional teams to drive root cause analysis and continuous improvement.

Bachelor’s degree in Engineering with 3 years of experience; familiarity with 21 CFR 820, ISO 13485, ISO

Qualifications

• Bachelor’s degree in Engineering or related field with 3 years’ experience.
• Experience with quality engineering policies, regulatory standards (21 CFR 820, ISO 13485, ISO 14971, IEC 62304).
• Software V&V experience; software development in regulated environments; familiarity with SAFe.

Responsibilities

• Manage all quality aspects of the design control process.
• Provide guidance on quality system and design controls.
• Review design artifacts for compliance with QMS and good documentation practices.
• Collaborate with program managers to ensure deliverables meet release timelines.
• Drive root cause analysis and structured problem solving for development and manufacturing issues.
• Ensure product technical files and Design History Files are complete and auditable.
• Lead continuous improvement across cross-functional teams.

Skills

Quality engineering

Regulatory knowledge

Software V&V

SAFe

Root cause analysis

Education

Bachelor’s degree in Engineering or related field

Tools

QA tools

Regulatory standards

Job description

BD is seeking a core team quality representative for design control projects, focusing on new product development and sustaining efforts in San Diego. You will manage quality planning, verification/validation, risk management, and regulatory support, ensuring traceability and conformance to QMS, working with cross-functional teams to drive root cause analysis and continuous improvement.

Bachelor’s degree in Engineering with 3 years of experience; familiarity with 21 CFR 820, ISO 13485, ISO