New · posted Nov 5
Abbott · Medical Devices
Senior Software Quality Engineer
- Sylmar, CA
- On-site
- Full-time
- Senior & Principal
The role
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.
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.
What you need
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.
What you'll do
- 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.
Pay and benefits
$90,000 – $180,000 a year
Employer providedThe base pay for this position is
$90,000.00 – $180,000.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage through Health Investment Plan (HIP) PPO
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Sylmar, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Sylmar, CAWorking conditions
Standard
TRAVEL
Yes, 5 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
JOB FAMILY
Operations Quality
DIVISION
CRM Cardiac Rhythm Management
LOCATION
United States > Sylmar : 15900 Valley View Court
From the posting
About Abbott
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.
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
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)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Software Quality & CSV roles at this level.
This roleEmployer provided
Senior & Principal roles in California8 roles publishing pay
Senior & Principal roles in the US28 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $90,000 | — | $180,000 |
| California (middle half) | $127,750 | $135,500 | $158,375 |
| All US (middle half) | $114,000 | $133,250 | $149,250 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Software Quality & CSV roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Software Quality & CSV
The general path across 52 open Software Quality & CSV roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems13
- GMP and compliance7
- Quality systems and risk7
- Collaboration and leadership7
- Validation and qualification4
- Lab testing and methods2
- Documentation and SOPs2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Software Quality & CSV work in medical devices, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system softwareNamed in the posting
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device softwareNamed in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devicesNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- IMDRFIMDRF(official source, opens in a new tab)International Medical Device Regulators Forum guidance, including software as a medical device
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
Company hiring pulse
Abbott on Regulatory Jobs
- 109
- Open roles
- 97
- Distinct roles
- 34
- Locations
By discipline
- Quality57 52%
- Regulatory30 28%
- Clinical21 19%
By level
- Senior & Principal51 47%
- Associate & Specialist31 28%
- Manager23 21%
More roles at Abbott
- View role
Senior Quality Assurance Engineer – Non-Product Software Validation
Irving, TXSenior & PrincipalMedical Devices$78K–$156K
- View role
IT Quality & Regulatory Assurance Manager
Waukegan, ILManagerMedical Devices$99K–$199K
- View role
Principle Professional Quality - Software
Lake Forest, ILSenior & PrincipalMedical Devices$99K–$199K
- View role
Lead, Quality Systems & Digital Transformation
Plano, TXSenior & PrincipalMedical Devices$87K–$173K
Similar Software Quality & CSV roles elsewhere
- View role
Senior Software Verification & Validation Engineer
RxSightAliso Viejo, CASenior & PrincipalMedical Devices$100K–$130K
- View role
Senior Software Quality Engineer
Outset MedicalSan Jose, CASenior & PrincipalMedical Devices$136K
- View role
Staff Software Quality Engineer
Outset MedicalSan Jose, CASenior & PrincipalMedical Devices$155K
- View role
Principal Engineer, Software Quality
Becton DickinsonIrvine, CASenior & PrincipalMedical Devices$130K–$207K
Senior Software Quality Engineer at Abbott
Open until filled. $90K–$180K a year, employer provided.