Senior Software Quality Engineer

Abbott; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott in Sylmar, CA is seeking a Software Quality Engineer to ensure software applications and infrastructure for cloud-based medical devices meet regulatory and quality requirements. You will collaborate with Development, DevOps, Product, and Regulatory teams to deliver secure, compliant software solutions for patient care.

The role emphasizes SDLC support, risk management, audits, and continuous improvement in a highly matrixed environment.

Qualifications

• Minimum 7 years of Software Quality Engineering experience.
• Detailed knowledge of IEC 62304, ISO 14971, ISO 13485, FDA Design Controls, FDA CSA, Medical Device Cybersecurity Guidance, Software Validation Principles, IEEE 1012.
• Advanced computer skills including statistical/data analysis and report writing.
• Advanced IT and data mining skills.
• ASQ CSQE certification desired.
• Ability to travel approximately 5-25%, including internationally.

Responsibilities

• Support all phases of the Software Development Lifecycle (SDLC) from requirements through post-market support.
• Review lifecycle deliverables and ensure alignment with Design Control requirements and risk management.
• Evaluate impact of software changes on requirements, testing, and regulatory compliance.
• Assist in maintaining risk management files for software and system risks.
• Lead quality and compliance assessments for software defects and product issues with proper risk evaluations and CAPAs.
• Evaluate verification/validation strategies and traceability to ensure compliant releases.
• Support internal and external audits and regulatory inspections with objective evidence.
• Drive continuous improvement and support investigations and CAPAs.
• Serve as software compliance and design assurance SME among cross-functional teams.
• Support Quality Management Systems and regulatory requirements.

Skills

Software quality engineering

Regulatory standards familiarity

Statistical analysis

Data mining

Report writing

Team collaboration

Travel readiness

Education

Bachelor's degree in Engineering or technical field

Equivalent combination of education and work experience

Tools

ASQ CSQE certification

Cybersecurity guidelines knowledge

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

MAIN PURPOSE OF THE ROLE

This is an ONSITE role based out of Sylmar, CA

This position is responsible for software quality, compliance, and design assurance activities associated with cloud-based medical device applications and supporting infrastructure. This role ensures software systems are developed, verified, validated, and maintained in compliance with applicable medical device regulations, quality system requirements, cybersecurity standards, and design control processes.

The position works closely with Development, Systems, DevOps, Product Management, Clinical Affairs, Cybersecurity, and Regulatory Affairs team to deliver secure, reliable, and compliant software solutions that support patient care and business objectives.

MAIN RESPONSIBILITIES

• Support all phases of the Software Development Lifecycle (SDLC), including requirements development, architecture, implementation, verification, validation, release management, post-market support, and continuous improvement.
• Review software lifecycle deliverables, participate in design and release reviews, and ensure software development activities align with Design Control requirements, software lifecycle standards, and risk management processes throughout the product lifecycle.
• Participate in change impact assessments by evaluating the impact of software changes on product requirements, risk controls, testing, system performance, and regulatory compliance.
• Assist in the 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, ensuring appropriate risk evaluations, impact assessments, and escalation processes are executed to support timely customer communications, regulatory reporting evaluations, and corrective action activities
• Evaluate verification and validation strategies, test coverage, traceability, and defect management activities to ensure requirements, risk controls, cybersecurity considerations, and intended use are adequately addressed and supported by objective evidence for compliant product releases
• Support internal audits, external audits, regulatory inspections, and compliance assessments by providing objective evidence and subject matter expertise related to software lifecycle and design control processes.
• Drive continuous improvement activities 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 ensure quality and compliance considerations are integrated throughout product development and maintenance activities.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

QUALIFICATIONS

Education

• Bachelors Degree (± 16 years) in an Engineering or Technical Field

(OR)

• An equivalent combination of education and work experience

Experience/Background

• Minimum 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, IEEE 1012.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Advanced Information Technology and data mining skills.
• Prior medical device experience preferred. ASQ CSQE certification desired.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 5-25%, including internationally.

The base pay for this position is $90,000.00 - $180,000.00. In specific locations, the pay range may vary from the range posted.