Senior Software Quality Engineer

Abbott • Los Angeles, CA

3d • $90,000 - $180,000 • Onsite

About The Position

This onsite position is based in Sylmar, California. The Senior Software Quality Engineer is responsible for software quality, compliance, and design assurance for cloud-based medical device applications and supporting infrastructure. The role ensures software is developed, verified, validated, and maintained in accordance with applicable medical device regulations, quality system requirements, cybersecurity standards, and design control processes.

The position works with Development, Systems, DevOps, Product Management, Clinical Affairs, Cybersecurity, and Regulatory Affairs teams to deliver secure, reliable, and compliant software supporting patient care and business objectives. It supports the software development lifecycle, design and release reviews, risk management, audits, investigations, corrective and preventive actions, and continuous improvement. The role also supports company initiatives related to quality and environmental management systems and other regulatory requirements.

The role requires a bachelor's degree in an engineering or technical field, or an equivalent combination of education and work experience, and at least seven years of Software Quality Engineering experience. Travel is approximately 5–25%, including internationally; the posting also lists travel as 5% of the time. The base pay range is $90,000–$180,000, with possible variation by location.

Requirements

• Bachelor's degree in an engineering or technical field, or an equivalent combination of education and work experience.
• At least 7 years of Software Quality Engineering experience.
• Detailed knowledge of IEC 62304, ISO 14971, ISO 13485, FDA Design Controls, FDA Computer Software Assurance (CSA), Medical Device Cybersecurity Guidance, Software Validation Principles, and IEEE 1012.
• Advanced computer skills, including statistical and data analysis and report writing.
• Advanced Information Technology and data mining skills.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work both as part of a team and as an individual contributor in a fast-paced, changing environment.
• Ability to engage others to accomplish projects.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.
• Strong organizational and follow-up skills and attention to detail.
• Ability to travel approximately 5–25%, including internationally.

Nice To Haves

• Prior medical device experience preferred.
• ASQ CSQE certification desired.
• Experience working in a broader enterprise or cross-division business unit model preferred.

Responsibilities

• Support all phases of the Software Development Lifecycle, from requirements development and architecture through implementation, verification, validation, release management, post-market support, and continuous improvement.
• Review software lifecycle deliverables, participate in design and release reviews, and ensure development activities align with Design Control requirements, software lifecycle standards, and risk management processes.
• Participate in change impact assessments, evaluating effects on product requirements, risk controls, testing, system performance, and regulatory compliance.
• Assist with completion and maintenance of risk management files focused on software- and system-related risks.
• Lead quality and compliance assessments for software defects and product issues, including risk and impact evaluations and escalation processes supporting customer communications, regulatory reporting evaluations, and corrective actions.
• Evaluate verification and validation strategies, test coverage, traceability, and defect management to ensure requirements, risk controls, cybersecurity considerations, and intended use are addressed with objective evidence for compliant product releases.
• Support internal and external audits, regulatory inspections, and compliance assessments by providing objective evidence and software lifecycle and design control expertise.
• Drive continuous improvement and support investigations, CAPAs, and compliance initiatives related to software products and processes.
• Serve as a software compliance and design assurance subject matter expert, partnering with cross-functional teams to integrate quality and compliance throughout product development and maintenance.
• Support company initiatives related to Quality Management Systems, Environmental Management Systems, and other regulatory requirements.
• Comply with FDA and other applicable regulations, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with employees, customers, contractors, and vendors at all levels.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, described as an affordable and convenient path to earning a bachelor's degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior