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Capa Manager Jobs in Connecticut (NOW HIRING)

Intellectt INC

Senior Quality Engineer

North Haven, CT · On-site

$88K - $119K/yr

Experience with CAPA, NCR, Root Cause Analysis, Process Validation, Change Control, and Risk Management . * Strong knowledge of statistical analysis and quality improvement tools. Preferred ...

Hobson & Motzer Inc

Manufacturing R&D Engineer

Durham, CT · On-site

$71K - $91K/yr

Responsibilities include process development, new product introduction, tooling and fixture design, root cause analysis, CAPA management, process validation, and documentation development. This ...

Intellectt INC

Sr. Quality Engineer

North Haven, CT · On-site

$88K - $119K/yr

... Experience with CAPA, NCR, Root Cause Analysis, Process Validation, Change Control, and Risk Management. · Strong knowledge of statistical analysis and quality improvement tools. Preferred ...

Vantedge

Manufacturing R&D Engineer

Durham, CT · On-site

$71K - $91K/yr

Responsibilities include process development, new product introduction, tooling and fixture design, root cause analysis, CAPA management, process validation, and documentation development. This ...

Rise Technical

Quality Engineering Manager

Derby, CT · On-site

Quality Engineering Manager $120,000 - $140,000 + Bonus + Profit Sharing + Progression + Training ... CAPA, SPC, Statistical Process Control, GD&T, Inspection, Quality Inspection, CMM, First Article ...

New

Vantedge Medical

Manufacturing R&D Engineer

Durham, CT · On-site

$71K - $91K/yr

Responsibilities include process development, new product introduction, tooling and fixture design, root cause analysis, CAPA management, process validation, and documentation development. This ...

Attalon, Inc.

Director of Quality

Bloomfield, CT · On-site

$152K - $262K/yr

Each business segment is supported by its own local quality team, responsible for managing day-to ... CAPA & Continuous Improvement : Direct the corporate Corrective and Preventive Actions (CAPA ...

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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 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 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 popular job titles related to Capa Manager jobs in Connecticut? For Capa Manager jobs in Connecticut, the most frequently searched job titles are:
What job categories do people searching Capa Manager jobs in Connecticut look for? The top searched job categories for Capa Manager jobs in Connecticut are:
What cities in Connecticut are hiring for Capa Manager jobs? Cities in Connecticut with the most Capa Manager job openings:
Capa Manager jobs near you

Senior Quality Engineer

Intellectt INC

North Haven, CT • On-site

$88K - $119K/yr

Contractor

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Hello,

I hope you're doing well.

My name is Purna, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Quality Engineer based in North Haven, CT (Onsite)with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at purnasree.u@intellectt.com.

Role: Senior Quality Engineer
Location: North Haven, CT (Onsite)


Job Summary

Seeking a Senior Quality Engineer with experience in medical device quality systems, process validation, CAPA, and regulatory compliance. The ideal candidate will support manufacturing quality, investigations, process improvements, and validation activities while ensuring compliance with FDA and ISO requirements.

Key Responsibilities

  • Support manufacturing quality and product quality improvements.
  • Lead investigations for NCRs, CAPAs, deviations, and customer complaints.
  • Perform root cause analysis using tools such as 5 Why, Fishbone, and PFMEA.
  • Support IQ/OQ/PQ, process validation, and equipment qualification.
  • Review and approve validation protocols, engineering changes, and quality documentation.
  • Conduct risk assessments and participate in DFMEA/PFMEA activities.
  • Collaborate with Manufacturing, R&D, Regulatory, and Supplier Quality teams.
  • Ensure compliance with FDA, ISO 13485, and quality management system requirements.

Required Qualifications

  • Bachelor's degree in Engineering or related technical field.
  • 4+ years of Quality Engineering experience in a regulated manufacturing environment.
  • Experience with CAPA, NCR, Root Cause Analysis, Process Validation, Change Control, and Risk Management.
  • Strong knowledge of statistical analysis and quality improvement tools.

Preferred Qualifications

  • Medical device manufacturing experience.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, Minitab, SPC, DOE, and Lean Six Sigma.
  • Experience supporting audits, supplier quality, and continuous improvement initiatives.

Thanks & Regards,

Purnasree.U
Recruiter
Intellectt Inc 
Purnasree.u@intellectt.com
Desk number: 7324568346 EXT: 234