New · posted Nov 4
Edwards Lifesciences · Medical Devices
Data Analytics Quality Manager
- Irvine, CA
- On-site
- Full-time
- Manager
The role
Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-edge information technology. This supports our innovation and collaboration on a global scale, enabling our diverse teams to optimize both efficiency and success. As part of our IT team, your expertise and commitment will help facilitate our patient-focused mission by developing and enhancing technological solutions.
At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.
The manager for Data Analytics Quality Manager will be responsible for leading Quality System improvements, Quality Analytics Insights, and AI-enabled solutions to identify risks and trends, drive cross-functional projects and corrective actions, and strengthen operational effectiveness, compliance, and data-driven decision-making.
What you need
What you'll need (required)
• Bachelor's Degree or Equivalent in related field, 8 years’ quality and/or manufacturing environment in the medical device industry experience or equivalent work experience based on Edwards criteria or
• Master's Degree or equivalent in related field, 6 years’ experience quality and/or manufacturing environment in the medical device industry experience or equivalent work experience based on Edwards criteria
What else we look for (preferred)nice to have
• Excellent in business intelligence applications (e.g., Power BI, Tableau, Stream lit)
• Experience with Quality Systems, Post Market , Regulatory and Training data or equivalent work experience based on Edwards criteria
• Experience in authoring and executing validation for business intelligence reports
• Experience with databases (e.g., Snowflake, Databricks, JDE, MES, EQMS, LMS)
• Experience with programming languages (e.g, SQL, Python, etc)
• Excellent documentation, communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of Edwards’ policies, procedures, and guidelines relevant to quality systems
• Experience in architecting, developing and deploying business intelligence, analytics and reporting solutions to internal and external stakeholders
• Extensive understanding of medical devices regulations (e.g., FDA (21 CFR Part 820), ISO13485, and ISO 14971)
• Ability to transfer essential knowledge and mentor other team members on specialized skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast-paced environment
• Ability to represent leadership on sections of projects within a specific area interfacing with project managers and quality systems team
• Ability to consult in a project setting within specific sections
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
What you'll do
How you will make an impact
• Identify, lead and provide business process improvement solutions for Quality Systems, including reviewing and approving changes to procedures, to improve operation, efficiencies, and user experience
• Lead moderately complex projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on cross-functional teams
• Manage all phases of the small to medium quality systems (e.g.,Training, CAPA, NCR, Supplier, FCA, PRA)
• Review and approve changes to documentation associated with Quality Systems, as well as assessing effectiveness and approving recommendations of others
• Drive investigations of basic problems, perform robust root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional SMEs
• Review and identify actions from metrics
• Lead AI initiatives and deploy AI Agents to support operations
• Prepare and pre-review data and documents for integrity prior to presentation in internal and external audit activities
• Provide technical direction to lower level staff
• Other incidental duties assigned by Leadership
Pay and benefits
$121,000 – $171,000 a year
Employer providedFor California, the base pay range for this position is $121,000 - $171,000 (highly experienced).
Competitive salaries
Performance-based incentives
Wide variety of benefits programs
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CAEqual opportunity, accessibility and legal noticesEdwards Lifesciences's statements, word for word
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% below the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Manager roles in California8 roles publishing pay
Manager roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $121,000 | — | $171,000 |
| California (middle half) | $159,750 | $165,500 | $184,750 |
| All US (middle half) | $144,750 | $159,500 | $168,000 |
This role: Edwards Lifesciences's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 78 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Quality systems and risk8
- Documentation and SOPs6
- GMP and compliance4
- Investigations and CAPA2
- Data and digital systems2
- Lab testing and methods1
- Validation and qualification1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control 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
- 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
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 31
- Open roles
- 30
- Distinct roles
- 6
- Locations
By discipline
- Quality19 61%
- Regulatory6 19%
- Clinical6 19%
By level
- Senior & Principal20 65%
- Associate & Specialist5 16%
- Director3 10%
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Data Analytics Quality Manager at Edwards Lifesciences
Applications close November 6. $121K–$171K a year, employer provided.