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Capa Manager Jobs in Saugus, MA (NOW HIRING)

Ametek

Quality Manager

Chelmsford, MA · On-site

Lead management review processes and oversee CAPA effectiveness. * Serve as a subject matter expert in quality processes, offering real-time problem solving and guidance. * Review and approve key ...

Ametek

Quality Manager

Chelmsford, MA

$90K/yr

Lead management review processes and oversee CAPA effectiveness. * Serve as a subject matter expert in quality processes, offering real-time problem solving and guidance. * Review and approve key ...

Ametek

Quality Manager

Chelmsford, MA · On-site

Lead management review processes and oversee CAPA effectiveness. * Serve as a subject matter expert in quality processes, offering real-time problem solving and guidance. * Review and approve key ...

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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 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 job categories do people searching Capa Manager jobs in Saugus, MA look for?

The top searched job categories for Capa Manager jobs in Saugus, MA are:

What cities near Saugus, MA are hiring for Capa Manager jobs?

Cities near Saugus, MA with the most Capa Manager job openings:

Capa Manager jobs near you

Quality Manager

Ametek

Chelmsford, MA • On-site

Full-time

Posted 27 days ago

AMETEK rating

7.5

Company rating: 7.5 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

92nd of 159 rated electronics manufacturers

Job description

The Quality Manager is responsible for developing, implementing, and leading the Quality Management System (QMS) to ensure all products meet ISO 9001 standards, regulatory requirements, and customer expectations. This role drives a culture of continuous improvement and ensures the consistent delivery of high-quality products across the organization.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Lead and manage the Quality function, maintaining ISO 9001 certification through a continuous improvement approach.
  • Oversee and analyze key quality metrics, including warranty data, customer issues (CSIs), and internal nonconformance (MRRs), and lead regular quality review meetings.
  • Provide training, guidance, and support to ensure effective root cause analysis and corrective action (CAPA) processes across the organization.
  • Ensure company compliance with applicable global regulations, industry standards, and internal quality requirements.
  • Partner with cross-functional leaders to drive adoption and execution of the QMS throughout the organization.
  • Develop and implement quality programs, policies, and initiatives to improve overall performance.
  • Prepare and present quality metrics and analysis to leadership.
  • Lead management review processes and oversee CAPA effectiveness.
  • Serve as a subject matter expert in quality processes, offering real-time problem solving and guidance.
  • Review and approve key quality documentation, including procedures, audit reports, and customer-related quality agreements.
  • Stay current on quality standards, regulations, and best practices through ongoing education and training.
  • Lead internal and external audit activities (ISO and customer audits), including preparation and follow-up actions.
  • Maintain and continuously improve quality documentation within the QMS.
  • Conduct QMS training programs for employees across the organization.
  • Support data collection and reporting to drive business decisions and operational improvements.

REQUIRED EDUCATION AND EXPERIENCE:  

  • Minimum of 5 years of experience in a quality leadership role within a manufacturing environment.
  • Bachelor's Degree in related field required. Engineering degree preferred. 
  • Certification in Quality and/or Lean Manufacturing required.
  • Experience developing and maintaining ISO systems (e.g., ISO 9001, 14001, 45001, 13485).
  • Proven experience driving continuous improvement initiatives in a Lean manufacturing environment.
  • Six Sigma experience required; Green Belt preferred.
  • Experience leading Kaizen events or continuous improvement workshops preferred.
  • Demonstrated ability to influence change and drive results across cross-functional teams.
  • Strong analytical, communication, and interpersonal skills.
  • Advanced proficiency in Microsoft Office (Excel, Word, PowerPoint).
  • Demonstrated potential for advancement into senior leadership roles.

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