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Capa Manager Jobs in Connecticut (NOW HIRING)

Aptyx

This role supports quality system processes including CAPA, nonconformance management, document control, internal auditing, and external regulatory and customer audits while ensuring compliance with ...

Deloitte

System Test and Validation Lead

Hartford, CT · 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 ...

Deloitte

System Test and Validation Lead

Hartford, CT · 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 ...

Deloitte

System Test and Validation Lead

Stamford, CT · 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 ...

Deloitte

System Test and Validation Lead

Stamford, CT · 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 ...

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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

Manager- Global CAPA System

CooperCompanies

Trumbull, CT • On-site

Full-time

Medical, Retirement, PTO

Re-posted 14 days ago

Job description


About CooperSurgical
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Work location: Trumbull, CT or Livingston, NJ (on-site)
Scope:
The Manager, Global CAPA System is responsible for the governance and oversight of CooperSurgical's global Corrective and Preventive Action (CAPA) program. This role ensures that standardized, effective CAPA processes are implemented and maintained across the organization and are fully compliant with applicable global regulatory requirements, including but not limited to 21 CFR Part 820, 21 CFR Parts 210/211, ISO 13485, the FDA Quality Management System Regulation (QMSR), and the EU Medical Device Regulation (EU MDR).
Job Summary:
The Manager, Global CAPA System is responsible for designing, implementing, and sustaining an effective global CAPA system to ensure regulatory compliance, product quality, and continuous improvement across all regions and sites. This role provides strategic leadership, governance, and subject matter expertise for CAPA processes arising from, but not limited to, deviations, nonconformances, audit and inspection findings, product complaints, adverse events, trend analyses, and risk management outputs.
Responsibilities
  • Own and maintain the global CAPA program, including policies, procedures, workflows, and performance metrics.
  • Ensure alignment of CAPA processes with global regulatory requirements 21 CFR Part 820, 21 CFR Parts 210/211, ISO 13485, the FDA Quality Management System Regulation (QMSR), and the EU Medical Device Regulation (EU MDR).
  • Establish clear criteria for CAPA initiation, escalation, prioritization, effectiveness checks, and closure.
  • Serve as the global subject matter expert (SME) for CAPA-related regulatory expectations and best practices.
  • Lead, develop, and sustain high-performing global and site CAPA teams; set clear expectations, coach performance, and build deep technical expertise across sites in investigations, root cause analysis, CAPA effectiveness, and quality risk management.
  • Partner cross-functionally with Quality, Regulatory Affairs, Manufacturing, R&D, Supply Chain, and Commercial teams to drive effective root cause analysis, ensure timely closure of CAPAs, and prevent recurrence of quality issues.
  • Oversee CAPA activities resulting from, but not limited to, deviations, nonconformances, audit and inspection findings, product complaints, adverse events, trend analyses, and risk management outputs.
  • Review and approve root cause analyses using structured methodologies (e.g., 5 Whys, Fishbone, Fault Tree, FMEA, etc.).
  • Ensure CAPA action plans are scientifically sound, data-driven, risk-based, and sustainable.
  • Monitor CAPA effectiveness and ensure verification of lasting corrective/preventive outcomes.
  • Develop and maintain global CAPA KPIs, dashboards, and management review inputs.
  • Perform trending and statistical analysis to identify systemic issues, recurring failures, or emerging risks.
  • Lead continuous improvement initiatives to reduce CAPA cycle time, improve quality maturity, and enhance inspection readiness.
  • Act as CAPA lead during regulatory inspections, notified body audits, and internal quality audits, including responses to observations and non-conformances.
  • Ensure inspection-ready documentation and clear traceability from issue identification through CAPA closure.
  • Support regulatory commitments and post-approval change management as applicable.
  • Develop and deliver CAPA training programs for global stakeholders.
  • Mentor site CAPA owners and quality teams to strengthen root cause analysis and problem-solving capabilities.
  • Represent the site and CooperSurgical in external forums (as assigned), including industry events, conventions, seminars, and trainings, maintaining professionalism and protecting company and product reputation.
  • Perform other duties as assigned.

Travel: This position may require 5-10% domestic and/or international travel.
Qualifications
Knowledge, Skills and Abilities:
  • Demonstrated expertise in CAPA management, including root cause analysis, effectiveness checks, and lifecycle governance.
  • Strong working knowledge of applicable global regulatory and quality standards, including 21 CFR Part 820, 21 CFR Parts 210/211, ISO 13485, FDA QMSR, and EU MDR.
  • Experience supporting regulatory inspections, notified body audits, and internal quality audits, including CAPA-related observation remediation.
  • Proficiency with electronic Quality Management Systems (eQMS) and CAPA workflows (e.g., TrackWise, Veeva, MasterControl, etc.).
  • Proven ability to analyze quality data and trends to identify systemic issues and drive continuous improvement initiatives.
  • Proven ability to operate effectively within a matrixed global organization, influencing cross-functional teams.
  • Strong written and verbal communication skills, with the ability to influence cross-functional and global stakeholders.
  • Fluent English required; Spanish proficiency strongly preferred (or ability and willingness to quickly develop working proficiency.

Work Environment:
  • Onsite Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
  • Occasionally lift to 35 pounds.

Experience:
  • 8+ years of progressive quality experience in a regulated industry, with 3-5 years directly supporting or managing CAPA systems.
  • 5+ years of QA leadership experience with demonstrated ability to build, lead, and develop high-performing teams.

Education:
  • Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related discipline required. Master's degree preferred.

#LI-KA1
Our Benefits:
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $120,000.00 - $170,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

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