Top 20 Senior qa specialist Jobs in San Diego Ca

Quality Assurance Specialist II
REVA Medical, LLC —San Diego, CA
- $75,000 - $90,000 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Research
- Health insurance
- Dental insurance
Quick Apply
2d
Clinical - QA Associate, Clinical Studies
Medvacon Life Sciences, LLC —San Diego, CA
- $33 an hour
- 8 hour shift
- Mid-level
- Math
- Associate's degree
Sr Quality Assurance Specialist
Grifols —San Diego, CA
- $108,026.40 - $140,000.00 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Management
- Paid holidays
- Health insurance
14d
Analytical Chemist
GEI Consultants —San Diego, CA
- $60,000 - $85,000 a year
- Urgently hiring
- Microsoft Access
- Bachelor of Science
- Mid-level
- Profit sharing
- Commuter assistance
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Quality System Specialist (Veeva eQMS Specialist)
Viking Therapeutics, Inc. —San Diego, CA
- $95,000 - $115,000 a year
- System design
- Mid-level
- 3 years
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Quality Assurance Associate
REVA Medical, LLC —San Diego, CA
- $24 - $33 an hour
- Full-time
- Microsoft Word
- Microsoft Excel
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
2d
Senior Specialist 2, Information Technology Technical Support & Maintenance
Halozyme Therapeutics, Inc. —San Diego, CA
- $130,000 - $160,000 a year
- Full-time
- Analysis skills
- JavaScript
- Scripting
- Employee stock purchase plan
- Tuition reimbursement
IT Specialist II – PMIS
AECOM —San Diego, CA
- $78,000 - $115,000 a year
- Full-time
- Background check
- Computer Science
- Mid-level
- AD&D insurance
- Employee stock purchase plan
Sr. Specialist - Anatomic Pathology Lab - Full Time
Sharp HealthCare —San Diego, CA
- $67.07 - $96.93 an hour
- 8 hour shift
- 5 years
- Bachelor's degree
- Senior level
- Disability insurance
- Health insurance
Lead, Pathologists Assistant - Copley - Full Time
Sharp HealthCare —San Diego, CA
- $72.29 - $104.47 an hour
- 8 hour shift
- High school
- 3 years
- Bachelor's degree
- Disability insurance
- Health insurance
Contract Compliance Specialist
San Diego LGBT Community Center —San Diego, CA
- $24.72 - $27.28 an hour
- Full-time
- Microsoft Outlook
- Mid-level
- Continuous improvement
- Health insurance
- Dental insurance
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Senior Marketing Communications Specialist, Social Content Producer
Qualcomm —San Diego, CA
- $41.92 - $62.88 an hour
- Doctoral degree
- Mid-level
- Office
6d
Sr. Specialist CLS - Copley Lab - Day Shift - Full Time
Sharp HealthCare —San Diego, CA
- 8 hour shift
- 5 years
- Bachelor's degree
- Senior level
- Disability insurance
- Health insurance
Equipment Specialist, Senior - PR 1433
P E Systems, Inc. —Poway, CA
- Microsoft Outlook
- Bachelor of Science
- Driver's License
- Paid time off
Quick Apply
6d
Technical Support Manager
Cohu, Inc. —San Diego, CA
- Extended hours
- Microsoft Excel
- Oracle
- Bachelor of Science
Sr SEO Specialist
Red Door Interactive —San Diego, CA
- $70,000 - $85,000 a year
- Hybrid work
- 3 years
- Continuous improvement
- Senior level
- Wellness program
- Health savings account
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Lead Clinical Lab Scientist - Sharp Coronado - Variable Shift - Full Time
Sharp HealthCare —Coronado, CA
- 8 hour shift
- Hospital
- 5 years
- Senior level
- Disability insurance
- Health insurance
Senior Software Product Designer (UI/UX)
VECKTA Corporation —San Diego, CA
- Full-time
- 5 years
- Senior level
- Commercial
Quick Apply
14d
Senior Water Resource Engineer
GHD —San Diego, CA
- $116,000 - $175,000 a year
- Hybrid work
- 7 years
- Bachelor of Science
- Engineering
7d

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Quality Assurance Specialist II

REVA Medical, LLC
San Diego, CA

Quick Apply

Job Details

Full-time
$75,000 - $90,000 a year
2 days ago

Benefits

Health insurance
Dental insurance
401(k)
Vision insurance

Qualifications

Research

Full Job Description

Quality Assurance Specialist

Job Purpose

The Quality Assurance Specialist is an experienced individual contributor who independently owns and operates defined Quality Management System processes and exercises judgment on routine and moderately complex quality and compliance matters. The position serves as a subject matter expert for assigned quality systems, drives timely resolution of quality events, supports product disposition and regulatory activities, analyzes quality system performance, and leads defined process improvements with minimal oversight.

The QA Specialist works collaboratively with the QA Associate and Sr. Quality Systems Engineer. The QA Associate provides day-to-day administration for document control, training, and asset management, while the QA Specialist provides process expertise, escalation support, backup coverage, and quality-system oversight as assigned. The Sr. Quality Systems Engineer partners with the QA Specialist on complex investigations, risk management, system design, validation/CSA, statistical analysis, and cross-functional quality-system improvements. The QA Specialist does not have direct supervisory responsibility for the QA Associate unless specifically assigned.

Batch Release

Own and execute assigned batch release activities, ensuring release decisions and documentation are completed in accordance with approved procedures, product requirements, and applicable regulatory requirements.
Evaluate routine release discrepancies and coordinate resolution or escalation of issues requiring additional technical, regulatory, or management review.
Train and support qualified personnel in batch release procedures and Electronic Batch Record (EBR) capabilities as new systems are introduced.
Partner with Operations and the Sr. Quality Systems Engineer to model, implement, and improve EBR processes and associated controls.

Quality Events – NCMR, DeviationCAPA

Serve as process owner or primary QA subject matter expert for assigned NCMR, deviation, and CAPA processes, ensuring records are appropriately initiated, investigated, reviewed, approved, and closed within established timelines.
Triage quality issues raised across the organization and determine the appropriate quality-system pathway, escalation, and required follow-up.
Lead or support investigations and structured root cause analysis for routine and moderately complex quality events; partner with the Sr. Quality Systems Engineer and technical functions on complex, systemic, or cross-functional investigations.
Assess quality events for potential impact to released product, product disposition, validation status, regulatory commitments, and risk management activities, escalating as appropriate.
Drive CAPA timelines, evaluate adequacy of corrections/corrective actions and effectiveness activities, and train employees on successful execution of quality event processes.
Monitor quality event trends and recommend systemic actions or process improvements when adverse or recurring patterns are identified.

Asset Management – Process Oversight

Serve as QA process owner/subject matter expert for the calibration and preventive maintenance quality system, with day-to-day scheduling, record maintenance, and tracking administered by the QA Associate.
Review and assess overdue, out-of-tolerance, incomplete, or otherwise non-conforming asset situations and determine or coordinate required quality-system actions.
Provide training, procedural guidance, and backup coverage for asset management activities and drive improvements to the calibration/preventive maintenance process.
Partner with the Sr. Quality Systems Engineer and equipment owners on qualification, validation, technical assessments, or systemic equipment-control issues as appropriate.

Regulatory SubmissionInspection Support

Research, organize, analyze, and present historical quality and manufacturing data in support of FDA submissions and responses to agency questions, including PMA-related activities.
Support preparation for FDA inspections, Notified Body audits, ISO 13485 audits, customer audits, supplier audits, and internal audits.
Lead or support audit backroom activities, including request management, record retrieval coordination, response tracking, and communication with subject matter experts.
Serve as a Quality Assurance subject matter expert during audits and inspections for assigned quality-system processes.

Risk Management, StandardsQuality Engineering Partnership

Ensure relevant quality events and post-production information are evaluated for potential linkage to product risk management activities.
Partner with the Sr. Quality Systems Engineer and technical functions on updates to Risk Management Files, risk probabilities, and other ongoing risk-management activities.
Apply structured Root Cause Analysis methodologies and appropriate data analysis to quality investigations; engage the Sr. Quality Systems Engineer for complex statistical, technical, or systemic analyses.
Support gap analyses of new and revised standards and regulations applicable to company products and quality systems in partnership with the Sr. Quality Systems Engineer and Regulatory Affairs.
Participate in implementation of resulting quality-system changes and verify completion of assigned actions.

Document Control, TrainingeQMS

Serve as a subject matter expert and escalation resource for document control and training processes administered day-to-day by the QA Associate.
Provide backup coverage for document control, training administration, and related quality records when needed and appropriately trained.
Review or approve controlled documents within assigned authority and provide guidance to authors and process owners on Quality System requirements.
Conduct or coordinate GMP/QMS and process-specific training as assigned.
Partner with the QA Associate and Sr. Quality Systems Engineer on eQMS implementation, migration, workflow design, testing, validation/CSA activities, and ongoing process improvement.
Define or contribute Quality Assurance requirements for eQMS workflows involving quality events, document control, training, batch release, and other assigned processes.
Update SOPs and Work Instructions to align with approved quality-system and eQMS processes.

Audits, MetricsQuality System Improvement

Schedule and coordinate the internal audit program as assigned and support remediation and closure of audit findings.
Compile, analyze, and present monthly quality metrics and identify trends requiring management attention or further investigation.
Compile and analyze information for Management Review and support preparation of Quality Management System performance summaries.
Lead defined quality-system improvement projects and track action items, timelines, risks, and deliverables.
Provide quality guidance to Operations, Product Development, and other functions on assigned Quality System processes and escalate decisions outside assigned authority.

Cross-Functional CoordinationBackup

Coordinate closely with the QA Associate to maintain continuity of document control, training, asset management, and other assigned Quality Assurance processes; provide cross-training and backup coverage without direct supervisory responsibility.
Interface routinely with the Sr. Quality Systems Engineer on investigations, risk management, validation/CSA, eQMS implementation, standards, data analysis, and systemic quality improvements.
Train and guide personnel on assigned Quality System processes and may provide functional direction for specific activities or projects.
Perform other duties and quality projects as assigned.

Skills / Qualifications

Bachelor's degree in a scientific, engineering, technical, or related discipline and typically 3–5 years of Quality Assurance/Regulatory Affairs experience in a regulated industry; medical device highly preferred. Relevant experience may be accepted in lieu of degree.
Working knowledge of ISO 13485 and 21 CFR Part 820 (Quality Management System Regulation/QMSR); exposure to FDA submission processes, including PMA activities, preferred.
Familiarity with ISO 14971 risk management principles, structured Root Cause Analysis methodologies, and quality-system data analysis.
Demonstrated ability to independently manage quality-system processes such as CAPA, NCMR/deviation, calibration/preventive maintenance oversight, document/training systems, or batch release with minimal supervision.
Experience supporting regulatory, Notified Body, customer, or internal audits and ability to serve as a subject matter expert for assigned processes.
Strong analytical, problem-solving, written, and verbal communication skills, including the ability to train and guide personnel and communicate quality issues to cross-functional stakeholders.
Proficiency with Microsoft Word, Excel, PowerPoint, and electronic Quality Management Systems (eQMS).
Ability to balance independent process ownership with effective collaboration, escalation, and cross-functional decision-making.
Positive, collaborative, and accountable working style with willingness to take on additional tasks and projects as assigned.

Quick Apply

Refine Your Search

senior qa specialist jobs in san diego ca

Quality Assurance Specialist II

Clinical - QA Associate, Clinical Studies

Sr Quality Assurance Specialist

Analytical Chemist

Quality System Specialist (Veeva eQMS Specialist)

Quality Assurance Associate

Senior Specialist 2, Information Technology Technical Support & Maintenance

IT Specialist II – PMIS

Sr. Specialist - Anatomic Pathology Lab - Full Time

Lead, Pathologists Assistant - Copley - Full Time

Contract Compliance Specialist

Senior Marketing Communications Specialist, Social Content Producer

Sr. Specialist CLS - Copley Lab - Day Shift - Full Time

Equipment Specialist, Senior - PR 1433

Technical Support Manager

Sr SEO Specialist

Lead Clinical Lab Scientist - Sharp Coronado - Variable Shift - Full Time

Senior Software Product Designer (UI/UX)

Senior Water Resource Engineer

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