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Capa Manager Jobs in Manchester, NH (NOW HIRING)

Getinge

Manager, Operations, Beta Bags

Merrimack, NH · On-site

The Manager will have direct oversight of the manufacturing resources, and influence over ... Participate in investigations and CAPA when required. * Lead, coach and develop an efficient team ...

Getinge

Manager, Operations, Beta Bags

Merrimack, NH · On-site

The Manager will have direct oversight of the manufacturing resources, and influence over ... Participate in investigations and CAPA when required. * Lead, coach and develop an efficient team ...

PCI Pharma Services

Sr. Automation Engineer

Bedford, NH · On-site

$102K - $134K/yr

The incumbent will develop support models to assure robust operations, manage vendor and software ... CAPA & Safety related corrective actions and manufacturing support. Participate in Control System ...

PCI Pharma Services

Sr. Automation Engineer

Bedford, NH · On-site

$102K - $134K/yr

The incumbent will develop support models to assure robust operations, manage vendor and software ... CAPA & Safety related corrective actions and manufacturing support. Participate in Control System ...

Asahi America

Be Seen First

Quality Manager Thermoplastic Piping & Valves

Lawrence, MA · On-site

$83K - $116K/yr

Asahi/America is looking for a Quality Manager to lead our quality initiatives, enhance our systems ... audits, CAPA, PPAP, and continuous improvement methodologies such as Lean and Six Sigma. You are ...

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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.

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Capa Manager jobs near you

Supplier Quality Engineer

Merrimack Manufacturing

Manchester, NH • On-site

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Company Overview:
Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.
Position Summary
The Supplier Quality Engineer (SQE) supports supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations within a regulated medical device environment. This role ensures supplier compliance to applicable requirements, including 21 CFR Part 820 and ISO 13485, and contributes to supplier qualification, development, monitoring, and performance management activities.
The SQE serves as a key interface between Engineering, Procurement, Quality, and the supplier base, supporting the assurance that suppliers consistently meet defined quality, regulatory, and performance expectations. This role supports supplier qualification activities for NPI programs, including onboarding of new suppliers, documentation review, and participation in process validation and design transfer activities. The SQE also supports sustaining supplier quality activities for production materials and services, including monitoring supplier performance and supporting resolution of supplier-related quality issues.
Key Responsibilities
Supplier Qualification & NPI Support
  • Support supplier qualification activities for New Product Introduction (NPI) projects
  • Conduct supplier assessments in accordance with established risk-based procedures
  • Support supplier selection activities in collaboration with Engineering, Procurement, and Quality
  • Participate in supplier audits (remote and onsite) as part of qualification and surveillance activities
  • Review supplier documentation including certifications, quality records, and validation evidence
  • Support supplier readiness activities for production launch, including process and quality system evaluations
  • Participate in design transfer and process validation activities involving suppliers
Sustaining Supplier Quality Management
  • Support supplier quality oversight for assigned NPI projects and production suppliers
  • Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
  • Support supplier corrective action activities (SCAR/CAPA) and ensure timely closure
  • Conduct supplier performance reviews and drive continuous improvement initiatives
  • Support containment, root cause analysis, and resolution of supplier-related quality issues
  • Perform risk-based supplier re-evaluations and periodic assessments
Supplier Quality System & Compliance
  • Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
  • Maintain and improve Approved Supplier List (ASL) classification and risk-based controls
  • Support external and internal audits involving supplier quality systems
  • Ensure supplier quality agreements are established and maintained
  • Drive adherence to change notification and supplier control requirements
Cross-Functional Collaboration
  • Partner with Design Authority (customer), Procurement, Manufacturing and Engineering
  • Support material nonconformance investigations and disposition decisions
  • Provide supplier risk input to project teams and change control processes
  • Support supply continuity and risk mitigation strategies

Qualifications
Education & Experience
  • Bachelor's degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.
  • 1-3 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
  • Strong knowledge of ISO 13485 and medical device regulatory requirements
  • Understanding of quality systems and regulatory expectations (21 CFR Part 820, ISO 13485)
  • Exposure to supplier quality, manufacturing, or inspection processes preferred
  • Experience supporting NPI, manufacturing, or engineering projects a plus
Skills & Competencies
  • Good analytical and problem-solving skills
  • Ability to work effectively in cross-functional teams
  • Strong communication and documentation skills
  • Ability interpret mechanical drawings (CAD files)
  • Attention to detail and commitment to quality
  • Ability to manage multiple tasks in a dynamic environment
  • Basic understanding of manufacturing and quality systems concepts
  • Familiarity with CAPA, nonconformance, or inspection processes is a plus
  • Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 10-20% travel
Preferred Certifications
  • ISO 13485 Internal Auditor certification (or willingness to obtain).
  • ASQ certifications (CQE, CQA, or similar) are a plus.

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