New · posted Nov 11
Abbott · Medical Devices
Lead Specialist Quality Assurance
- Sylmar, CA
- On-site
- Full-time
- Senior & Principal
The role
MAIN PURPOSE OF THIS ROLE
We are seeking a highly qualified Quality Assurance Lead Specialist in Sylmar, CA to conduct quality-related activities to deliver consistent, high quality documents, services, products and processes. Ensure compliance with world wide regulatory expectations/requirements.
This is an ONSITE role.
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.
A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
What you need
Education
- Bachelors Degree (± 16 years) In life sciences or engineering or an equivalent combination of education and work experience.
- Preferred degree in Data Science, Statistics, Biostatistics, Computer Science, Engineering, Mathematics, Quality Engineering, or a related quantitative field.
Experience/Background
- Minimum 4 years of experience applying data analytics, statistical modeling, and data science techniques in a regulated industry such as Medical Devices, Pharmaceuticals, Biotechnology, or Healthcare.
- Strong proficiency in Python, R, SQL, SAS, or similar analytical programming languages.
- Experience with machine learning, predictive analytics, anomaly detection, and pattern recognition methodologies.
- Advanced knowledge of statistical analysis techniques including hypothesis testing, regression analysis, multivariate analysis, survival analysis, DOE (Design of Experiments), SPC (Statistical Process Control), and time-series analysis.
- Experience working with large and complex datasets from Manufacturing, Quality Systems, Complaints, CAPA, Nonconformance, Supplier Quality, and Post-Market Surveillance systems.
- Proficiency with data visualization and business intelligence tools such as Power BI, Infinity QS.
- Experience developing interactive dashboards, automated reporting solutions, and executive-level data presentations.
- Strong understanding of data governance, data integrity, and validation principles in regulated environments.
- Demonstrated capability to translate complex analytical findings into actionable business recommendations.
What you'll do
- Responsible for independently executing advanced quality data analytics and investigation activities with minimal management oversight.
- Lead cross-functional data-driven initiatives focused on quality improvement, risk reduction, process optimization, and regulatory compliance.
- Analyze large and complex datasets from CAPA, Complaints, Nonconformances, Supplier Quality, Manufacturing, and Post-Market Surveillance systems to identify trends, signals, and root causes.
- Develop innovative, practical, and compliant analytical solutions to address complex quality and operational challenges.
- Apply statistical methods, machine learning models, and predictive analytics to proactively detect emerging quality issues and support decision-making.
- Design, develop, and maintain dashboards, automated reports, and quality performance metrics to provide actionable insights across the organization.
- Demonstrate expertise in data science, statistical analysis, and quality systems while continuously expanding technical and leadership competencies.
- Identify opportunities for continuous improvement through data-driven analysis and recommend sustainable solutions.
- May provide technical guidance and mentorship to analysts, quality professionals, data scientists, and contractors.
- Maintain specialized expertise in Quality Analytics while leveraging knowledge of manufacturing, regulatory, engineering, and business processes.
- Collaborate closely with Quality, Operations, Engineering, Regulatory Affairs, Clinical, and Supply Chain teams to solve complex business problems.
- Represent the Data Science and Quality Analytics function on cross-functional projects and strategic initiatives.
- Implement tactical and strategic analytics activities to support quality objectives and business priorities.
- Contribute advanced statistical and data science expertise broadly across business functions.
- Directly influence project direction, investigation strategies, analytical methodologies, and quality risk management decisions through evidence-based insights.
- Support regulatory inspections, management reviews, CAPA effectiveness assessments, and quality system monitoring through robust data analysis and visualization.
- Ensure data integrity, governance, and compliance with applicable requirements including FDA 21 CFR Part 820, ISO 13485, and internal quality management system standards.
Pay and benefits
$100,000 – $200,000 a year
Employer providedThe base pay for this position is
$100,000.00 – $200,000.00
In specific locations, the pay range may vary from the range posted.
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
At Abbott, you can have a good job that can grow into a great career. We offer:
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal
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
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 27% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California21 roles publishing pay
Senior & Principal roles in the US64 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $100,000 | — | $200,000 |
| California (middle half) | $113,500 | $142,000 | $156,000 |
| All US (middle half) | $93,375 | $118,000 | $150,500 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 340 open Quality Assurance 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 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Lab testing and methods7
- Quality systems and risk7
- Investigations and CAPA5
- GMP and compliance4
- Data and digital systems4
- Documentation and SOPs2
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
Company hiring pulse
Abbott on Regulatory Jobs
- 117
- Open roles
- 117
- Distinct roles
- 34
- Locations
By discipline
- Quality62 53%
- Regulatory30 25%
- Clinical25 21%
By level
- Senior & Principal57 48%
- Associate & Specialist33 28%
- Manager25 21%
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Lead Specialist Quality Assurance at Abbott
Open until filled. $100K–$200K a year, employer provided.