Top 393 Senior quality specialist Jobs in Irvine, Ca

Senior Labeling Specialist
Edwards Lifesciences —Irvine, CA
- $92,000 - $130,000 a year
- Full-time
- 5 years
- English
- Bachelor's degree
Senior Regulatory Affairs Specialist
Boston Scientific —Irvine, CA
- $89,200 - $169,500 a year
- Hybrid work
- Research
- Office
- Analysis skills
Senior Specialist - Quality Engineering
LTM —Irvine, CA
- $103,415 - $152,000 a year
- SQL
- Senior level
- Python
- Paid parental leave
- Paid holidays
Quick Apply
5d
Senior Paid Google Ads Specialist
Sweet James —Newport Beach, CA
- $85,000 - $110,000 a year
- Full-time
- Office
- Analysis skills
- Bachelor's degree
- Free parking
- Health savings account
Quick Apply
Senior Traffic Analyst
Aspen Environmental Group —California
- $115,000 - $145,000 a year
- Email
- Remote
- Microsoft Excel
- Data analysis skills
- 11+ years
Quick Apply
Process Improvement Specialist
MSI —Orange, CA
- $23 - $24 an hour
- Overtime
- Microsoft Excel
- Microsoft Outlook
- Analysis skills
- Disability insurance
- Health insurance
8h
Sr. Regulatory Affairs Specialist
Prismatik Dentalcraft —Irvine, CA
- $86,000 - $120,000 a year
- Full-time
- Microsoft Outlook
- 5 years
- Research
- Health insurance
- Dental insurance
Quick Apply
Shower Door B2B Sales and Field Technician Specialist- Orange County
Eurotech Showers inc. —Orange County, CA
- $60,000 - $80,000 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Construction site
- Health insurance
- Dental insurance
Quick Apply
Sr. Client Relationship Manager, Employee Benefits - IAS, West
The Baldwin Group —Irvine, CA
- $100,000 - $110,000 a year
- Full-time
- Finance
- Analysis skills
- Bachelor's degree
Senior Sales Account Executive
OEC Group —Cerritos, CA
- $80,000 - $120,000 a year
- Full-time
- Microsoft Excel
- ERP systems
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
Environmental Compliance Project Manager
CDMS —Long Beach, CA
- $90,000 - $115,000 a year
- Full-time
- Hybrid work
- Mid-level
- Office
- Master's degree
- Health savings account
- Health insurance
3d
Senior Appliance Repair Technician – High-End & Sealed System Specialist
More Than a Fix Appliance Repair —San Clemente, CA
- $1,500 - $5,000 a week
- Part-time
- Clean driving record
- Schematics
- Customer service
- Relocation assistance
- Professional development assistance
Quick Apply
Senior Accounting Specialist
AIVITA BIOMEDICAL INC —Irvine, CA
- $76,000 - $86,000 a year
- Full-time
- Office
- Finance
- Bachelor's degree
- AD&D insurance
- Disability insurance
6d
Technology Services Manager, Senior
County of Orange —Santa Ana, CA
- $140,670.40 - $194,833.60 a year
- Full-time
- HIPAA
- Mentoring
- Senior level
4d
Veterinarian
Global Veterinary Careers —Orange County, CA
- $115,000 - $220,000 a year
- Part-time
- Inpatient
- Mid-level
- US work authorization
- Continuing education credits
- Paid parental leave
Quick Apply
5d
Behavior Technician (FULLTIME)
Uplift ABA Behavior Services —Fountain Valley, CA
- $20 - $25 an hour
- Part-time
- Experience working with individuals with developmental disabilities
- Applied behavior analysis
- High school diploma or GED
- Paid training
- Mileage reimbursement
Quick Apply
A-Level Automotive Technician| $40–$55/hr - 2099
Promotive —Mission Viejo, CA
- $40 - $55 an hour
- Full-time
- Background check
- 5 years
- Mentoring
- Paid training
- Health insurance
Quick Apply
6d
Operations Support Specialist - Property Management - In office - CORP
Aperto Property Management, Inc —Irvine, CA
- $26 - $33 an hour
- Full-time
- ERP systems
- Office
- 3 years
- Disability insurance
- Health insurance
Quick Apply
Registered Veterinary Technicians - Specialty, ER & Critical Care
AVSG Internal Medicine, Emergency & Critical Care —Tustin, CA
- $27 - $45 an hour
- 12 hour shift
- Mid-level
- Surgery
- Operating room
- Paid parental leave
- Health insurance
Quick Apply
Behavior Technician (FULLTIME)
Uplift ABA Behavior Services —Anaheim, CA
- $20 - $25 an hour
- Part-time
- Experience working with individuals with developmental disabilities
- Applied behavior analysis
- High school diploma or GED
- Paid training
- Mileage reimbursement
Quick Apply

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Senior Labeling Specialist

Edwards Lifesciences -
Irvine, CA

Apply Now

Job Details

Full-time
$92,000 - $130,000 a year

Qualifications

Data-driven problem-solving
Stakeholder management

Full Job Description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Labeling Specialist position is a unique career opportunity that could be your next step towards an exciting future.

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

How you’ll make an impact:

Collaborate with Business Units to set priorities and workflow milestones (e.g., NPD core team participation, regulatory changes, acquisitions, site transfers) and develop and maintain execution plans with target dates for new or revised content and cost-effective labeling solutions. Provide leadership on alternate strategies to accelerate timelines for critical projects. Lead solution development for labeling projects by recommending activities and solution modifications, guiding requestors and cross functional partners in defining labeling design requirements, and establishing agreement on content, format, and artifacts (e.g., IFU type documents, labels, implant cards) for complex labeling change packages.
Prepare, review, and approve labeling intake documentation and guide the labeling team on executing standard solutions on accelerated timelines for critical projects. Identify and develop complex solutions to meet Clinical, NPD, and Sustaining labeling change requests and demand planning requirements. Build alignment and consensus on execution plans for complex and high priority labeling change requests, ensuring clarity on solution details and alignment with project plans and deliverables.
Ensure accountabilities for all updates and changes to global labeling standards, procedures, training plans, and process improvements by routing and approving assigned labeling deliverables through CR and PLM processes in compliance with applicable standards and regulations.
Collaborate with vendors on translation projects, coordinating internal and external communications to meet timelines. Proactively identify translation issues, drive resolution, and manage translation project workflows.
Provide recommendations and regular reporting on activities, risks, and issue resolution across various business scenarios.
Evaluate risks and develop mitigation strategies to resolve critical path issues, while drafting and implementing process improvements that minimize disruption to daily and production activities. Identify and lead process improvement initiatives (e.g., Kaizen) by proposing, implementing, and training teams on new solutions that improve efficiency and effectiveness. Support to collect details for labeling operations metrics and support the execution of operations quality initiatives.
Lead the resolution of SCARs, NCR, and CAPAs by applying statistically valid data analysis, formal root cause methodologies, and driving effective corrective actions as a process owner.
Complete all required training on time, coach and develop BU Labeling team members by sharing and transferring knowledge, creating a labeling process playbook, and delivering content and process training to stakeholders.
Understanding of global regulatory requirements and standards relevant to the business. Partners with cross functional teams to interpret regulations and ensure compliant implementation in labeling. Proactively identifies and mitigates regulatory compliance risks.
Perform other incidental duties as required.

What you’ll need (Required):

Bachelor's Degree with 5 years of related work experience in a device/medical/pharmaceutical FDA regulated industry or equivalent work experience based on Edward's criteria

What else we look for (Preferred):

Demonstrate strong technical proficiency with the MS Office Suite, with experience using MS Project preferred.
Communicate effectively through clear written and verbal communication, strong interpersonal skills, and the ability to negotiate, build relationships, and drive alignment toward shared objectives.
Establish and maintain grammatical and formatting standards, templates, and style guides to ensure consistency and quality across labeling deliverables.
Exhibit strong leadership and influence, with a demonstrated ability to lead change and drive adoption of improved processes and solutions.
Plan, manage, and deliver projects successfully by adhering to schedules, managing dependencies, and maintaining accountability for outcomes.
Read, write, comprehend, and speak English fluently to ensure accuracy and clarity in regulated labeling content.
Apply a strong understanding of domestic and global labeling development and implementation requirements.
Interpret and apply medical and/or pharmaceutical regulations and standards to ensure compliant labeling solutions.
Leverage extensive knowledge of medical device documentation development activities throughout the product lifecycle.
Work effectively within CR, PLM, and CAPA processes to manage labeling changes and quality events.
Demonstrate strong problem-solving capabilities, supported by effective organizational, analytical, and critical thinking skills.
Apply solid project management practices to balance scope, timelines, and quality across multiple initiatives.
Maintain strict attention to detail in all documentation and execution activities.
Interact professionally across all organizational levels, including frequent engagement with senior internal and external stakeholders on complex matters requiring cross organizational coordination.

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.

For California, the base pay range for this position is $92,000 - $130,000 (highly experienced).

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.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Apply Now

Refine Your Search

senior quality specialist jobs in irvine, ca

Senior Labeling Specialist

Senior Regulatory Affairs Specialist

Senior Specialist - Quality Engineering

Senior Paid Google Ads Specialist

Senior Traffic Analyst

Process Improvement Specialist

Sr. Regulatory Affairs Specialist

Shower Door B2B Sales and Field Technician Specialist- Orange County

Sr. Client Relationship Manager, Employee Benefits - IAS, West

Senior Sales Account Executive

Environmental Compliance Project Manager

Senior Appliance Repair Technician – High-End & Sealed System Specialist

Senior Accounting Specialist

Technology Services Manager, Senior

Veterinarian

Behavior Technician (FULLTIME)

A-Level Automotive Technician| $40–$55/hr - 2099

Operations Support Specialist - Property Management - In office - CORP

Registered Veterinary Technicians - Specialty, ER & Critical Care

Behavior Technician (FULLTIME)

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