Manage quality assurance project activities (e.g., CAPA) with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality ...
Manage quality assurance project activities (e.g., CAPA) with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality ...
Medical Device Complaint Trending Expert (Any Facility)
West Valley City, UT · On-site
$81K - $112K/yr
Partner with Complaint Handling, CAPA, and Risk Management teams to translate trend signals into formal investigations and actions * Collaborate with Medical Safety, Clinical, and Regulatory teams to ...
Medical Device Complaint Trending Expert (Any Facility)
West Valley City, UT · On-site
$81K - $112K/yr
Partner with Complaint Handling, CAPA, and Risk Management teams to translate trend signals into formal investigations and actions * Collaborate with Medical Safety, Clinical, and Regulatory teams to ...
Partner with Complaint Handling, CAPA, and Risk Management teams to translate trend signals into formal investigations and actions * Collaborate with Medical Safety, Clinical, and Regulatory teams to ...
Partner with Complaint Handling, CAPA, and Risk Management teams to translate trend signals into formal investigations and actions * Collaborate with Medical Safety, Clinical, and Regulatory teams to ...
Quality Technician
Salt Lake City, UT · On-site
$58K - $110K/yr
... management systems, and experience performing receiving, in-process, final, and First Article Inspections (FAI). * Experience conducting root cause analysis, corrective and preventive actions (CAPA ...
Quality Technician
Salt Lake City, UT · On-site
$58K - $110K/yr
... management systems, and experience performing receiving, in-process, final, and First Article Inspections (FAI). * Experience conducting root cause analysis, corrective and preventive actions (CAPA ...
Manage RMA (Return Merchandise Authorization) and warranty return programs, performing defect trend analysis and enforcing permanent corrective actions (CAPA) with suppliers. * Conduct root cause ...
Manage RMA (Return Merchandise Authorization) and warranty return programs, performing defect trend analysis and enforcing permanent corrective actions (CAPA) with suppliers. * Conduct root cause ...
Supplier Quality and Reliability Engineer
Salt Lake City, UT · On-site
$85 - $140/hr
Manage RMA (Return Merchandise Authorization) and warranty return programs, performing defect trend analysis and enforcing permanent corrective actions (CAPA) with suppliers. * Conduct root cause ...
New
Supplier Quality and Reliability Engineer
Salt Lake City, UT · On-site
$85 - $140/hr
Manage RMA (Return Merchandise Authorization) and warranty return programs, performing defect trend analysis and enforcing permanent corrective actions (CAPA) with suppliers. * Conduct root cause ...
New
Quality Technician
Salt Lake City, UT · Hybrid
$17.50 - $23.50/hr
... management systems, and experience performing receiving, in-process, final, and First Article Inspections (FAI). * Experience conducting root cause analysis, corrective and preventive actions (CAPA ...
Quality Technician
Salt Lake City, UT · Hybrid
$17.50 - $23.50/hr
... management systems, and experience performing receiving, in-process, final, and First Article Inspections (FAI). * Experience conducting root cause analysis, corrective and preventive actions (CAPA ...
Quality Technician
Salt Lake City, UT · Hybrid
$110K/yr
... management systems, and experience performing receiving, in-process, final, and First Article Inspections (FAI). * Experience conducting root cause analysis, corrective and preventive actions (CAPA ...
Quality Technician
Salt Lake City, UT · Hybrid
$110K/yr
... management systems, and experience performing receiving, in-process, final, and First Article Inspections (FAI). * Experience conducting root cause analysis, corrective and preventive actions (CAPA ...
Quality Technician
Salt Lake City, UT · On-site
$17.50 - $23.50/hr
... management systems, and experience performing receiving, in-process, final, and First Article Inspections (FAI). * Experience conducting root cause analysis, corrective and preventive actions (CAPA ...
Quality Technician
Salt Lake City, UT · On-site
$17.50 - $23.50/hr
... management systems, and experience performing receiving, in-process, final, and First Article Inspections (FAI). * Experience conducting root cause analysis, corrective and preventive actions (CAPA ...
Supplier Quality and Reliability Engineer
Salt Lake City, UT · On-site
$85 - $140/hr
Manage RMA (Return Merchandise Authorization) and warranty return programs, performing defect trend analysis and enforcing permanent corrective actions (CAPA) with suppliers. * Conduct root cause ...
Supplier Quality and Reliability Engineer
Salt Lake City, UT · On-site
$85 - $140/hr
Manage RMA (Return Merchandise Authorization) and warranty return programs, performing defect trend analysis and enforcing permanent corrective actions (CAPA) with suppliers. * Conduct root cause ...
Quality Specialist
Provo, UT · On-site
$60K - $65K/yr
Experience with CAPA procedures preferred * Experience with Food Grade preferred * Experience with ... Manage the Food Fraud program, including risk assessments and maintains applicable documentation ...
Quality Specialist
Provo, UT · On-site
$60K - $65K/yr
Experience with CAPA procedures preferred * Experience with Food Grade preferred * Experience with ... Manage the Food Fraud program, including risk assessments and maintains applicable documentation ...
Quality Specialist
Provo, UT · On-site
$60K - $65K/yr
Experience with CAPA procedures preferred * Experience with Food Grade preferred * Experience with ... Manage the Food Fraud program, including risk assessments and maintains applicable documentation ...
New
Quality Specialist
Provo, UT · On-site
$60K - $65K/yr
Experience with CAPA procedures preferred * Experience with Food Grade preferred * Experience with ... Manage the Food Fraud program, including risk assessments and maintains applicable documentation ...
New
Leadership Management: Lead and coach the plant leadership team. Ensure clear development goals ... Support audits and ensure timely completion of corrective actions (CAPA). * Additional Duties:
Leadership Management: Lead and coach the plant leadership team. Ensure clear development goals ... Support audits and ensure timely completion of corrective actions (CAPA). * Additional Duties:
Leadership Management: Lead and coach the plant leadership team. Ensure clear development goals ... Support audits and ensure timely completion of corrective actions (CAPA). * Additional Duties:
Leadership Management: Lead and coach the plant leadership team. Ensure clear development goals ... Support audits and ensure timely completion of corrective actions (CAPA). * Additional Duties:
Quality supervisor
Salt Lake City, UT · On-site
Lead Design for Manufacturing/Assembly (DFM/DFA) and establish process risk management controls ... Root Cause Analysis (RCA), CAPA, 8D, Six Sigma * Manufacturing & Tools: SPC, Lean Manufacturing
Quality supervisor
Salt Lake City, UT · On-site
Lead Design for Manufacturing/Assembly (DFM/DFA) and establish process risk management controls ... Root Cause Analysis (RCA), CAPA, 8D, Six Sigma * Manufacturing & Tools: SPC, Lean Manufacturing
Recommend and implement corrective and preventive actions (CAPA) to reduce defects and improve ... Bachelor's degree in Engineering, Quality Management, or a related technical field (or equivalent ...
Recommend and implement corrective and preventive actions (CAPA) to reduce defects and improve ... Bachelor's degree in Engineering, Quality Management, or a related technical field (or equivalent ...
Quality supervisor
Salt Lake City, UT · On-site
Lead Design for Manufacturing/Assembly (DFM/DFA) and establish process risk management controls ... Root Cause Analysis (RCA), CAPA, 8D, Six Sigma * Manufacturing & Tools: SPC, Lean Manufacturing
Quality supervisor
Salt Lake City, UT · On-site
Lead Design for Manufacturing/Assembly (DFM/DFA) and establish process risk management controls ... Root Cause Analysis (RCA), CAPA, 8D, Six Sigma * Manufacturing & Tools: SPC, Lean Manufacturing
Quality Engineer
Ogden, UT · On-site
$70K - $91K/yr
Quality Assurance Manager with dotted line to CFT Team Lead Direct Reports: No Direct reports for ... Quality background to include CAPA problem solving and root cause analysis * Strong mechanical ...
Quality Engineer
Ogden, UT · On-site
$70K - $91K/yr
Quality Assurance Manager with dotted line to CFT Team Lead Direct Reports: No Direct reports for ... Quality background to include CAPA problem solving and root cause analysis * Strong mechanical ...
Quality Supervisor
Ogden, UT · On-site
$82K - $90K/yr
They manage quality policies, standards, and processes, drive departmental efficiency, and lead the ... They support regulatory inspections, non-conformance responses, and CAPA execution. The Supervisor ...
Quick apply
Quality Supervisor
Ogden, UT · On-site
$82K - $90K/yr
They manage quality policies, standards, and processes, drive departmental efficiency, and lead the ... They support regulatory inspections, non-conformance responses, and CAPA execution. The Supervisor ...
This position is responsible for monitoring adherence to food safety standards, managing non ... Lead investigations and root cause analysis for, and oversee the development of CAPA, including ...
This position is responsible for monitoring adherence to food safety standards, managing non ... Lead investigations and root cause analysis for, and oversee the development of CAPA, including ...
Capa Manager information
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 are the key skills and qualifications needed to thrive as a CAPA manager?
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 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 popular job titles related to Capa Manager jobs in Utah?
For Capa Manager jobs in Utah, the most frequently searched job titles are:
What job categories do people searching Capa Manager jobs in Utah look for?
The top searched job categories for Capa Manager jobs in Utah are:
What cities in Utah are hiring for Capa Manager jobs?
Cities in Utah with the most Capa Manager job openings:
Senior Manager, Quality Engineering & Quality Assurance
Salt Lake City, UT • On-site
Full-time
Posted 5 days ago
Edwards Lifesciences rating
8.3
Based on 30 frontline employees who took The Breakroom Quiz
67th of 540 rated manufacturers
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 Manager, Quality Engineering & Quality Assurance position is a unique career opportunity that could be your next step towards an exciting future.
The Senior Manager, Quality Engineering & Quality Assurance will manage the Metal Manufacturing team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in process and finished goods. Oversee process audits and final product release documentation. Advise and facilitate failure investigations, compliance methodologies for manufacturing of Metal Components. Manage team with activities that focus on implementing and optimizing quality engineering practices while ensuring a culture of quality and compliance with global regulatory requirements.
How You'll Make an Impact:
What You'll Need (Required):
What Else We Look For (Preferred):
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
The Senior Manager, Quality Engineering & Quality Assurance will manage the Metal Manufacturing team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in process and finished goods. Oversee process audits and final product release documentation. Advise and facilitate failure investigations, compliance methodologies for manufacturing of Metal Components. Manage team with activities that focus on implementing and optimizing quality engineering practices while ensuring a culture of quality and compliance with global regulatory requirements.
How You'll Make an Impact:
- Quality representative for Metals associated with internal and external audits. Coordinate with Draper Quality Systems Management for audit preparation, execution and action plans. Ensure Metals Organization executes to Draper site quality objectives/plans
- Manage supervisors and/or oversee the work of assigned quality assurance team within own function, one or more production line or projects. Develop a robust talent development plan in alignment with functional growth strategies of the department. Identify opportunities and lead the implementation of changes to drive improvements
- Manage quality assurance project activities (e.g., CAPA) with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality objectives including training, approvals, and system effectiveness. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional groups
- Collaborate with cross-functional groups to manage inspection of in-process and finished goods, assemblies and components including proper implementation
- Negotiate solutions with cross-functional groups (e.g., Manufacturing Operations, Supply Chain, and Engineering) for continuous improvement
- Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
- Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department
- Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity. Collaborate with Campus Model shared services to support Draper Metals Organization.
What You'll Need (Required):
- Bachelor's degree in related field related experience in Materials, Chemical, Mechanical and/or Metals engineering.
- Experience in Quality Engineering or Quality Management within the medical device industry with demonstrated Product Quality decision-making, or equivalent work experience based on Edwards' criteria.
- Demonstrated track record in management of technical and/or engineering disciplines in a dynamic Quality/Manufacturing Environment.
What Else We Look For (Preferred):
- Technical quality leadership experience supporting metals manufacturing, metal components, or precision-manufactured components.
- Experience supporting commercial production quality for processes such as machining, forming, chemical processing, laser cutting, tubing, nitinol, or other metal component manufacturing processes.
- Demonstrated experience leading both Quality Engineering and Quality Assurance functions, including oversight of NCRs, CAPAs, TMVs, inspection readiness, product release, and quality metrics.
- Experience managing Supervisors and associated direct and indirect manufacturing inspection and/or testing resources.
- Experience managing or partnering closely with inspection, quality control, and manufacturing operations teams to ensure in-process and finished goods meet quality, compliance, and release requirements.
- Medical Device external audit leadership experience
- Proven ability to serve as a quality representative during internal, notified body, FDA, customer, or external regulatory audits, including audit preparation, execution, response, and action plan management.
- Strong working knowledge of applicable medical device quality system and regulatory requirements, including FDA Quality System Regulation, ISO 13485, GMP, and global quality standards.
- Experience using quality engineering tools and statistical methods such as process capability, statistical process control, FMEA, DOE, test method validation, root cause analysis, Lean, and Six Sigma.
- Demonstrated ability to lead technical quality investigations, drive risk-based decision-making, and implement sustainable corrective and preventive actions in a high-volume or complex manufacturing environment.
- Experience developing and using quality metrics, management review inputs, and operational dashboards to monitor trends, communicate risks, and drive continuous improvement.
- Certified Quality Engineer, Six Sigma Black Belt, Lean certification, or equivalent quality/manufacturing certification.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
What Edwards Lifesciences employees say
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About Edwards Lifesciences
Sourced by ZipRecruiter
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
Industry
Medical equipment and supplies manufacturing
Company size
10,000+ Employees
Headquarters location
Irvine, CA, US
Year founded
1958