Senior Software Quality Engineer

3205 St. Jude Medical, Cardiology Division, I; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Free HIP PPO medical plan next year

Retirement savings plan with high-empr

Tuition reimbursement / FreeU

Job summary

Abbott is seeking an onsite Software Quality Engineer in Sylmar, CA to ensure software quality, compliance, and design assurance for cloud-based medical device applications and supporting infrastructure. The role collaborates with Development, Systems, DevOps, Product Management, Clinical Affairs, Cybersecurity, and Regulatory Affairs to deliver secure, reliable software that meets regulatory requirements.

The position requires a Bachelor's degree in engineering, 7+ years of software quality

Qualifications

• Education: Bachelor’s Degree in Engineering or Technical Field or equivalent.
• Minimum 7 years of Software Quality Engineering experience.
• Knowledge of IEC 62304, ISO 14971, ISO 13485, FDA Design Controls, FDA CSA, Cybersecurity Guidance, IEEE 1012.

Responsibilities

• Support all SDLC phases including requirements, architecture, implementation, verification, validation, release management, and post-market support.
• Review lifecycle deliverables and ensure alignment with Design Controls and risk management.
• Lead risk assessments and CAPAs related to software defects and regulatory compliance.
• Provide evidence for audits and regulatory inspections; support continuous improvement.

Skills

IEC 62304

ISO 14971

ISO 13485

FDA Design Controls

FDA Computer Software Assurance

Medical Device Cybersecurity Guidance

Software Validation Principles

IEEE 1012

Statistical analysis

Report writing

Education

Bachelor's Degree in Engineering or Technical Field

Tools

Statistical software

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.

JOB DESCRIPTION

Working 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.

• 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.

JOB FAMILY: Operations Quality
DIVISION: CRM Cardiac Rhythm Management
LOCATION: United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
WORK SHIFT: Standard
TRAVEL: Yes, 5 % of the Time
MEDICAL SURVEILLANCE: Not Applicable
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

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.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Follow Us: Facebook LinkedIn YouTube Twitter