Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required. * Chair the monthly AOD (Analysis of Data) meeting if required. * Prepare and present CAPA data at the monthly meeting if ...
Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required. * Chair the monthly AOD (Analysis of Data) meeting if required. * Prepare and present CAPA data at the monthly meeting if ...
Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required. * Chair the monthly AOD (Analysis of Data) meeting if required. * Prepare and present CAPA data at the monthly meeting if ...
Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required. * Chair the monthly AOD (Analysis of Data) meeting if required. * Prepare and present CAPA data at the monthly meeting if ...
Quality Engineer
Bonita Springs, FL ยท On-site
$67K - $87K/yr
Strong knowledge of CAPA, root cause analysis, process validation, SPC, and risk management. * Experience in a contract manufacturing (CMO/CDMO) environment preferred. Preferred Certifications * ASQ ...
Quality Engineer
Bonita Springs, FL ยท On-site
$67K - $87K/yr
Strong knowledge of CAPA, root cause analysis, process validation, SPC, and risk management. * Experience in a contract manufacturing (CMO/CDMO) environment preferred. Preferred Certifications * ASQ ...
Quality Assurance & Quality Control Manager
Bonita Springs, FL ยท On-site
$120K/yr
Own the CAPA system, driving timely identification, investigation, and resolution of issues ... Manage quality lab operations to ensure timely, efficient inspection and release of product
Quick apply
Quality Assurance & Quality Control Manager
Bonita Springs, FL ยท On-site
$120K/yr
Own the CAPA system, driving timely identification, investigation, and resolution of issues ... Manage quality lab operations to ensure timely, efficient inspection and release of product
Sr. Manager - Quality Assurance
Davie, FL ยท On-site
Key responsibilities include developing Quality Control Plans, utilizing data to enhance Quality Control and CAPA operations, and validating test methods. The manager reviews and approves critical ...
Sr. Manager - Quality Assurance
Davie, FL ยท On-site
Key responsibilities include developing Quality Control Plans, utilizing data to enhance Quality Control and CAPA operations, and validating test methods. The manager reviews and approves critical ...
System Test and Validation Lead
Lake Mary, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Lake Mary, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Lake Mary, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Lake Mary, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Miami, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Miami, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Miami, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Miami, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tampa, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tampa, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tampa, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tampa, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Jacksonville, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Jacksonville, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tallahassee, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tallahassee, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Miami, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Miami, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tallahassee, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tallahassee, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Jacksonville, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Jacksonville, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Jacksonville, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Jacksonville, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Lake Mary, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Lake Mary, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tallahassee, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tallahassee, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tampa, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
System Test and Validation Lead
Tampa, FL ยท On-site +1
This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address ...
Capa Manager information
See Florida salary details
$10.91 - $14.17
2% of jobs
$14.17 - $17.43
5% of jobs
$17.43 - $20.68
8% of jobs
$20.68 - $23.94
8% of jobs
$24.30 is the 25th percentile. Wages below this are outliers.
$23.94 - $27.19
9% of jobs
$27.19 - $30.45
8% of jobs
The median wage is $32.81 / hr.
$30.45 - $33.70
11% of jobs
$33.70 - $36.96
21% of jobs
$37.19 is the 75th percentile. Wages above this are outliers.
$36.96 - $40.21
15% of jobs
$40.21 - $43.47
6% of jobs
$43.47 - $46.72
5% of jobs
$10
$32
$46
How much do capa manager jobs pay per hour?
What is the role of a Capa specialist?
What does a CAPA Manager do?
A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.
What is a capa coordinator?
What is the highest paying manager position?
What are some common challenges a CAPA Manager faces, and how are they typically addressed?
One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.
What are the key skills and qualifications needed to thrive in the Capa Manager position, and why are they important?
To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.
What does a capa manager do?

Full-time
Medical, Dental, Vision, Retirement
Posted 12 days ago
Job description
Ability and knowledge to conduct the work listed in at least one of the 5 major job Duties and Responsibilities(excluding General Duties), so that they contribute to company compliance with relevant laws and regulations.
Essential Responsibilities
Regulatory (Supporting Responsibility)
- Actively engage in pre-/post-market regulatory activities, which include but are not limited to the following:
- Review and approval of product labeling.
- Review of FDA submissions.
- Assist/work with consultants as needed.
- Support R&D with 510(k) submissions.
- Create Regulatory Master Plans for product launches.
- Lead the development of new product labeling and oversee the labeling program to coordinate the review, approval, and tracking of all product labeling.
- Act as the subject matter expert on UDI.GUDID regulations.
- Manage FDA facility registrations and device listings.
- Manage FDA import inspections, provide FDA data and information to US Customs, and work with both the FDA and US Customs to resolve shipments placed on hold.
- Write Health Risk Assessments for Nonconforming products, customer complaints and MDRs.
- Review ECRs.
- Support Sales and Marketing to resolve any FDA compliance questions or concerns from customers.
Science (Supporting Responsibility)
- Support Medical Lab Scientists of the Smart Assist project.
- Support clinical studies as needed. Including but not limited to hands-on assistance in the clinical studies.
- Train and support the Clinical Application Specialists and Field Service Engineers in their activities.
- Perform other pre-/post-market activities as assigned.
Quality Assurance/Quality Management System (Primary Responsibility)
- Manage the supplier databases for our major retail-chain partner.
- Manage the Validation Program, Change Control Review, and approve Supplier Change Requests.
- Coordinate the review, approval, and tracking of all Engineering Changes from our suppliers.
- Review and approve ECRs.
- Manage various Quality System databases.
- Oversee software validations.
- Fulfill the role of internal auditor. Also, manage the Internal Audit Program.
- Prepare supplier audits and scorecards. Also, manage the Supplier Approval Program.
- Conduct External Audits.
- Assemble the monthly AOD presentation materials and present the training data.
- Perform Quality Acceptance Inspections on products that are to be delivered to a 3rd-party logistics company and then perform the shipment permission inspection on products that are to be shipped from the 3rd-party logistics company.
- Act as the Quality Plan Manager for Product Launches if required.
- Ensure compliance with FDA QMSR, ISO 13485, and OSHA.
- Fulfill the role of OSHA Safety Coordinator for our Miami Facility and any new facilities that may be added in the future.
- Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required.
- Chair the monthly AOD (Analysis of Data) meeting if required.
- Prepare and present CAPA data at the monthly meeting if required.
Complaint Handling (Supporting Responsibility)
- Oversees Post Market Surveillance - Customer Complaints.
- Create the Monthly Risk Review Report.
- Manage Product Recalls and other field actions.
- Manage our Lab Division's Complaint Program and coordinate External Complaint with AFC (factory headquarters in Japan).
- Chair the Lab Division's monthly Complaint Meeting.
- Present the Lab Division's Complaints in the monthly AOD meeting.
- Review Technical Bulletins.
- Manage the Healthcare Division's Complaint Program.
- Chair the Healthcare Division's monthly Complaint Meeting.
- Present the Healthcare Division's Complaints in the monthly AOD meeting.
- Submit MDRs to the FDA.
- Create the Monthly Vendor Reporting.
- Review the Daily Call Data of our major retail-chain partner.
General Duties
- Act as the Facilities and Equipment Manager of our Miami location.
- Pick up and process company mail.
- Coordinate activities for the Miami Facility and Office.
This job description is not intended to be all-inclusive and the employee will also perform other reasonably related business duties as assigned by management.
Knowledge and Skills
- Bachelor's Degree in chemistry, biology, engineering or other technical field required.
- Two or more years of experience working in a regulated diagnostic industry required.
- Senior roles will require seven or more years of experience working in a regulated diagnostic industry required.
- Experience working with Class I and Class II medical devices, preferably laboratory, and Point of Care IVD instruments and reagents that are subject to US regulatory submission.
- Knowledge and working experience on FDA, GMP/QSR, ISO, CFR and/or other regulatory issues related to medical devices.
- Senior roles will require the ability to manage both undergoing ISO 13485 audits and conducting supplier audits in compliance with ISO 13485 standards.
- Knowledge on US regulatory submissions. Ability to build direct relationships and deal with the FDA in relation to the submission process is preferred.
- Clinical study management experience is preferred.
- Experience in quality systems and quality assurance activities.
- Proficiency in Microsoft Office programs (including, but not limited to Word, Adobe, Excel, PowerPoint)
- Ability to travel.
Physical Requirements
Heavy keyboarding / PC use
ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities. ARKRAY offers a generous benefit package that includes Medical, Dental, Vision, 401K w/company match, FSA and HSA options.