Compliance Audit Analyst
$97K - $98K/yr
Manage CAPA workstream, CAPA investigations, CAPA & compliance audit trending of quality data streams. 2. Develop & establish continuously improving plans for site CAPA system, quality assurance ...
$97K - $98K/yr
Manage CAPA workstream, CAPA investigations, CAPA & compliance audit trending of quality data streams. 2. Develop & establish continuously improving plans for site CAPA system, quality assurance ...
$97K - $98K/yr
Manage CAPA workstream, CAPA investigations, CAPA & compliance audit trending of quality data streams. 2. Develop & establish continuously improving plans for site CAPA system, quality assurance ...
Fremont, CA · On-site
$165K - $180K/yr
Lead and manage the CAPA, Complaint Handling, Nonconformance, and Audit programs to ensure compliance, effectiveness, and continuous improvement. * Ensure quality system processes are aligned with ...
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Fremont, CA · On-site
$165K - $180K/yr
Lead and manage the CAPA, Complaint Handling, Nonconformance, and Audit programs to ensure compliance, effectiveness, and continuous improvement. * Ensure quality system processes are aligned with ...
$60 - $75/hr
Lead RCCA and CAPA investigations for nonconformances, audit findings, and customer issues. * Perform root cause analysis using structured problem-solving methodologies (5 Whys, Fishbone, etc.
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$60 - $75/hr
Lead RCCA and CAPA investigations for nonconformances, audit findings, and customer issues. * Perform root cause analysis using structured problem-solving methodologies (5 Whys, Fishbone, etc.
Thousand Oaks, CA · On-site
$28 - $31/hr
This individual will own CAPA records from initiation through effectiveness verification, partner cross-functionally to drive investigations to closure, and contribute to continuous improvement ...
Thousand Oaks, CA · On-site
$28 - $31/hr
This individual will own CAPA records from initiation through effectiveness verification, partner cross-functionally to drive investigations to closure, and contribute to continuous improvement ...
Alameda, CA · On-site
$176 - $250.50/hr
Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management.* Provide guidance on Quality systems usage, process requirements, best practices ...
Alameda, CA · On-site
$176 - $250.50/hr
Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management.* Provide guidance on Quality systems usage, process requirements, best practices ...
Alameda, CA · On-site
$130 - $160/hr
Lead and partner QA support for deviations, change control, CAPA, CAPA actions, and effectiveness checks management. * Provide guidance on quality systems usage, process requirements, best practices ...
Alameda, CA · On-site
$130 - $160/hr
Lead and partner QA support for deviations, change control, CAPA, CAPA actions, and effectiveness checks management. * Provide guidance on quality systems usage, process requirements, best practices ...
Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management. * Provide guidance on Quality systems usage, process requirements, best practices ...
Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management. * Provide guidance on Quality systems usage, process requirements, best practices ...
Novato, CA · Hybrid
$52 - $62.06/hr
Change Control & CAPA Support * Support initiation and execution of change controls related to specification updates. * Coordinate impact assessments from affected functional groups. * Track ...
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Novato, CA · Hybrid
$52 - $62.06/hr
Change Control & CAPA Support * Support initiation and execution of change controls related to specification updates. * Coordinate impact assessments from affected functional groups. * Track ...
Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management. * Provide guidance on Quality systems usage, process requirements, best practices ...
Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management. * Provide guidance on Quality systems usage, process requirements, best practices ...
Novato, CA · Hybrid
$52 - $62.06/hr
Change Control & CAPA Support * Support initiation and execution of change controls related to specification updates. * Coordinate impact assessments from affected functional groups. * Track ...
Quick apply
Novato, CA · Hybrid
$52 - $62.06/hr
Change Control & CAPA Support * Support initiation and execution of change controls related to specification updates. * Coordinate impact assessments from affected functional groups. * Track ...
Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management. * Provide guidance on Quality systems usage, process requirements, best practices ...
Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management. * Provide guidance on Quality systems usage, process requirements, best practices ...
El Segundo, CA · On-site
$120K - $160K/yr
CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions. * Post-Market Surveillance (PMS): Design and ...
El Segundo, CA · On-site
$120K - $160K/yr
CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions. * Post-Market Surveillance (PMS): Design and ...
$120K - $160K/yr
CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions. * Post-Market Surveillance (PMS): Design and ...
Quick apply
$120K - $160K/yr
CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions. * Post-Market Surveillance (PMS): Design and ...
$40 - $50/hr
Heavily engage in CAPA deviation report writing and assist with corrective action investigations. * Gather information from team members and write manuals and other documentation. * Document ...
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$40 - $50/hr
Heavily engage in CAPA deviation report writing and assist with corrective action investigations. * Gather information from team members and write manuals and other documentation. * Document ...
El Segundo, CA · On-site
$120K - $160K/yr
CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions. * Post-Market Surveillance (PMS): Design and ...
El Segundo, CA · On-site
$120K - $160K/yr
CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions. * Post-Market Surveillance (PMS): Design and ...
South San Francisco, CA · On-site
$185K - $225K/yr
The role also serves as Quality System Owner for Rigel's CAPA Program and supports inspection readiness, Health Authority inspections, and partner audits to ensure compliance with applicable ...
South San Francisco, CA · On-site
$185K - $225K/yr
The role also serves as Quality System Owner for Rigel's CAPA Program and supports inspection readiness, Health Authority inspections, and partner audits to ensure compliance with applicable ...
Irvine, CA · On-site
$71K - $89K/yr
Monitor CAPA progress and ensure timely closure. Quality Systems Compliance * Ensure investigations comply with internal quality procedures and applicable regulatory requirements. * Support internal ...
Irvine, CA · On-site
$71K - $89K/yr
Monitor CAPA progress and ensure timely closure. Quality Systems Compliance * Ensure investigations comply with internal quality procedures and applicable regulatory requirements. * Support internal ...
Irvine, CA · On-site
Monitor CAPA progress and ensure timely closure. Quality Systems Compliance * Ensure investigations comply with internal quality procedures and applicable regulatory requirements. * Support internal ...
Irvine, CA · On-site
Monitor CAPA progress and ensure timely closure. Quality Systems Compliance * Ensure investigations comply with internal quality procedures and applicable regulatory requirements. * Support internal ...
San Diego, CA · On-site
$76K - $98K/yr
Knowledge of design controls, change control, validation, CAPA, complaint handling, post-market surveillance, nonconformance management, and quality system processes. * Understanding of risk ...
San Diego, CA · On-site
$76K - $98K/yr
Knowledge of design controls, change control, validation, CAPA, complaint handling, post-market surveillance, nonconformance management, and quality system processes. * Understanding of risk ...
San Diego, CA · On-site
$80K - $110K/yr
This role blends day-to-day quality system execution - documentation, CAPA support, and audit readiness - with ownership of the technical administration and project management needed to keep the ...
San Diego, CA · On-site
$80K - $110K/yr
This role blends day-to-day quality system execution - documentation, CAPA support, and audit readiness - with ownership of the technical administration and project management needed to keep the ...
$14.59 - $19.54
0% of jobs
$19.54 - $24.48
6% of jobs
$24.48 - $29.42
11% of jobs
$31.38 is the 25th percentile. Wages below this are outliers.
$29.42 - $34.37
20% of jobs
The median wage is $38.60 / hr.
$34.37 - $39.31
15% of jobs
$39.31 - $44.25
15% of jobs
$46.73 is the 75th percentile. Wages above this are outliers.
$44.25 - $49.20
16% of jobs
$49.20 - $54.14
9% of jobs
$54.14 - $59.08
4% of jobs
$59.08 - $64.03
2% of jobs
$64.03 - $68.97
2% of jobs
$14
$41
$68
A CAPA specialist is responsible for investigating quality issues, identifying root causes, and implementing corrective and preventive actions to ensure ongoing compliance and product integrity. Their typical day involves reviewing nonconformance reports, collaborating with cross-functional teams, documenting findings, and tracking the progress of CAPA initiatives using specialized software. CAPA specialists also prepare reports for audits and may facilitate meetings to drive continuous improvement activities. This role often requires balancing multiple projects and deadlines in a regulated environment, making organizational and communication skills crucial for success.
To thrive as a CAPA (Corrective and Preventive Action) specialist, you need expertise in quality management systems, root cause analysis, and compliance with industry standards, typically backed by a degree in engineering, life sciences, or a related field. Familiarity with CAPA software, regulatory frameworks (such as ISO 13485 or FDA 21 CFR Part 820), and document control systems is essential. Strong analytical thinking, attention to detail, and effective communication skills are vital soft skills for this role. These skills ensure effective problem-solving and sustained compliance, which are essential for maintaining product quality and meeting regulatory requirements.
A CAPA (Corrective and Preventive Action) job involves identifying, investigating, and resolving quality issues in industries like manufacturing, healthcare, and pharmaceuticals. CAPA professionals analyze root causes of defects or process failures and implement corrective actions to prevent recurrence. They ensure compliance with regulatory standards, document findings, and improve overall quality management systems. Their role is critical in maintaining product safety, efficiency, and regulatory adherence.

$97K - $98K/yr
Contractor
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 4 hours ago
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.Â
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.
. Manage CAPA workstream, CAPA investigations, CAPA & compliance audit trending of quality data streams.Â
2. Develop & establish continuously improving plans for site CAPA system, quality assurance programs & quality policies.Â
3. Plan, schedule & execute internal quality audits program for ventilation design sites.Â
4. Lead a team of auditor(s) to perform audits / assessments by collecting and analyzing objective evidence regarding issues and risks. Report findings (verbally and written) to management.Â
5. Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management, as appropriate.Â
6. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.Â
7. Develop and maintain compliance policies supporting the Respiratory and Monitoring quality system.Â
8. Lead process improvement projects and conduct training with Quality to improve the GBUs overall quality system compliance.Â
9. Assist with site regulatory compliance specific needs such as external audit preparation, assessment of quality plans, responses to internal and external audit observations.Â
10. Maintain working knowledge of existing and proposed domestic and international medical device regulations and guidance documents and their impact on Medtronic's operations.Â
11. Prepare management reports depicting trends and useful data for management review purposes.Â
12. Support management during external inspections and participate in the management of external inspections as required.Â
Auditing experience to the 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR and the Medical Device Directive.Â
Formal training in CAPA compliance & Investigation techniques.Â
Risk Management, ISO 14971, FTA, Design FMEA,Â
Comparative Statistical techniques & sampling plans.Â
To know more about this position please contact after applying to the position on;
Sagar Rathore
sagar.rathore(at)collabera.com
630-485-2166