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Capa Engineer Jobs in Exton, PA (NOW HIRING)

Hologic

CAPA Facilitator, Engineer

Newark, DE · On-site

$97K - $152K/yr

Hologic is seeking a Quality Engineer, CAPA Facilitator to support and strengthen Corrective and Preventive Action, CAPA, processes and broader quality assurance operations. This role will partner ...

Hologic Inc.

CAPA Facilitator, Engineer

Newark, DE · On-site

$97K - $152K/yr

Hologic is seeking a Quality Engineer, CAPA Facilitator to support and strengthen Corrective and Preventive Action, CAPA, processes and broader quality assurance operations. This role will partner ...

GSK

Facilities Electrical Engineer

Upper Providence, PA · On-site

Audit findings, CAPA, Engineering/EHS alerts, preventable disruptions, sustainability objectives. * Execute site assessments against Engineering Policies and Standards in support of real estate due ...

Talnt

Manufacturing Engineer

West Chester, PA · On-site

$90K - $130K/hr

The Manufacturing Engineer will support precision manufacturing, process engineering, and ... Experience with root cause analysis, corrective action, CAPA, Lean Manufacturing, continuous ...

Prophecy Technologies

R&D CSV Engineer

Wilmington, DE · On-site

The engineer will be responsible for applying core CSV principles and regulatory expertise within a ... Manage deviations and Corrective and Preventive Actions (CAPA), ensuring full compliance with ...

GWYNEDD

Quality Engineer

North Wales, PA

$69K - $89K/yr

The Quality Engineer will be responsible for developing and implementing quality assurance ... Participate in root cause analysis, corrective action, and preventive action activities (CAPA)

Qnity

Quality Engineer

Newark, DE · On-site

$70K - $90K/yr

Manage CAPA, SCAR, and continuous improvement activities to ensure timely and effective resolution ... Bachelor's degree in engineering or a related technical discipline with 2+ years of experience in ...

Ventura Solutions LLC

Quality Engineer

Norristown, PA · On-site

$68K - $88K/yr

... CAPA, SCAR), and contribute to supplier quality improvement programs; lead supplier qualifications ... Bachelor's degree in Engineering, Science, Math, or another related technical field. * At least 2 ...

Ventura Solutions LLC

Quality Engineer

Norristown, PA

$68K - $88K/yr

... CAPA, SCAR), and contribute to supplier quality improvement programs; lead supplier qualifications ... Bachelor's degree in Engineering, Science, Math, or another related technical field. * At least 2 ...

Ventura Solutions LLC

Quality Engineer

Norristown, PA · On-site

$68K - $88K/yr

... CAPA, SCAR), and contribute to supplier quality improvement programs; lead supplier qualifications ... Bachelor's degree in Engineering, Science, Math, or another related technical field. * At least 2 ...

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on ... Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to ...

Hologic Inc.

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on ... Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to ...

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All JobsCapa Engineer JobsCapa Engineer Jobs in Exton, PA

Capa Engineer information

See Exton, PA salary details

$37.6K

$98.2K

$132.7K

How much do capa engineer jobs pay per year?

As of Sep 10, 2026, the average yearly pay for capa engineer in Exton, PA is $98,206.00, according to ZipRecruiter salary data. Most workers in this role earn between $81,100.00 and $112,400.00 per year, depending on experience, location, and employer.

What is a CAPA engineer?

A CAPA (Corrective and Preventive Action) Engineer is responsible for identifying, investigating, and resolving quality issues in manufacturing or engineering processes. They analyze root causes of defects, implement corrective measures, and develop preventive strategies to ensure compliance with industry regulations. CAPA Engineers work closely with cross-functional teams to improve product quality, streamline processes, and maintain regulatory compliance. They also document findings, track action plans, and support continuous improvement initiatives to reduce future risks.

What are the main daily responsibilities of a CAPA engineer?

A CAPA Engineer's daily responsibilities typically include investigating potential or actual nonconformities, conducting root cause analyses, and developing corrective and preventive action plans to resolve and prevent future issues. They also collaborate closely with cross-functional teams such as manufacturing, quality assurance, and regulatory affairs to ensure solutions are practical and compliant with industry standards. Additionally, CAPA Engineers monitor the progress and effectiveness of implemented actions, prepare documentation for audits, and participate in continuous process improvement initiatives. This role is crucial for maintaining the highest quality standards and ensuring compliance in regulated industries such as medical devices or pharmaceuticals.

What are the key skills and qualifications needed to thrive in the CAPA engineer position, and why are they important?

To thrive as a CAPA Engineer, you need a solid background in quality engineering, root cause analysis, and process improvement, typically supported by a degree in engineering or a related technical field. Familiarity with CAPA management systems, quality standards such as ISO 13485 or ISO 9001, and tools like Six Sigma or FMEA is highly valuable. Strong problem-solving abilities, attention to detail, and effective communication skills distinguish top performers in this role. These competencies ensure effective identification, documentation, and resolution of quality issues, helping organizations maintain regulatory compliance and deliver high-quality products.

What are popular job titles related to Capa Engineer jobs in Exton, PA?

For Capa Engineer jobs in Exton, PA, the most frequently searched job titles are:

What job categories do people searching Capa Engineer jobs in Exton, PA look for?

The top searched job categories for Capa Engineer jobs in Exton, PA are:

Capa Engineer jobs near you
Infographic showing various Capa Engineer job openings in Exton, PA as of September 2026, with employment types broken down into 1% Internship, 86% Full Time, 10% Part Time, and 3% Contract. Highlights an 84% Physical, 5% Hybrid, and 11% Remote job distribution, with an average salary of $98,206 per year, or $47.2 per hour.

CAPA Facilitator, Engineer

Newark, DE • On-site

Hologic
Health Care and Social Assistance • 5 - 10K employees
Learn more about Hologicexternal

$97K - $152K/yr

Full-time

Posted 25 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

Job description


Hologic is seeking a Quality Engineer, CAPA Facilitator to support and strengthen Corrective and Preventive Action, CAPA, processes and broader quality assurance operations. This role will partner closely with Quality Management System, QMS, leadership and cross-functional teams to improve CAPA performance, support remediation efforts, build CAPA competency, and help sustain effective quality systems.
The ideal candidate brings strong experience in quality assurance within a regulated environment, particularly medical device, IVD, or pharmaceutical, and has demonstrated expertise in CAPA, root cause analysis, quality metrics, audit support, and continuous improvement.
Key Responsibilities CAPA System Leadership and Support
  • Serve as a subject matter expert for CAPA, including root cause analysis, effectiveness checks, and sustainable corrective actions.
  • Coordinate and facilitate CAPA Review Board meetings and related documentation.
  • Own and improve the divisional CAPA toolbox, including training materials, templates, and reference resources.
  • Monitor CAPA system health, conduct daily reviews for escalations, and coordinate with departments to support adequate resourcing.
  • Provide input into global CAPA process improvements and related training content.

Quality Assurance Operations
  • Support and model Hologic's quality values while promoting a culture of accountability, compliance, and continuous improvement.
  • Collaborate with junior staff, peers, and cross-functional stakeholders across multiple organizational levels.
  • Assist in the development, implementation, and maintenance of quality assurance procedures, processes, and documentation.
  • Proactively identify opportunities to strengthen QMS processes, including inputs to and outputs from CAPAs.
  • Analyze quality data and trends to identify improvement opportunities and systemic risks.
  • Develop and maintain CAPA and quality metrics, dashboards, and reporting tools.
  • Routinely partner with internal suppliers and stakeholders to review CAPA data, monitoring, and performance.

Audit and Compliance Support
  • Participate in and support internal and external audits, including FDA inspections, as a CAPA and quality systems subject matter expert.
  • Assist with audit preparation, data collection, and communication with functional areas to support audit readiness and efficiency.
  • Help ensure compliance with applicable FDA regulations, QMSR, ISO 13485, and other relevant global quality standards.

Training and Mentorship
  • Mentor and coach junior team members in CAPA and quality system fundamentals.
  • Provide consultation and training on CAPA principles, methodologies, and best practices to QMS and cross-functional teams.

Continuous Improvement and Special Projects
  • Lead or contribute to CAPA-related remediation projects and continuous improvement initiatives.
  • Support data analysis activities to develop key performance indicators across functions.
  • Review open Quality Plans, QPLs, and provide recommendations for updates or improvements.

Qualifications Education
  • Technical Bachelor's degree or higher preferred.

Experience
  • 3-8 years of experience in the medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems.
  • Experience with Agile or an equivalent Product Lifecycle Management system is beneficial.

Skills and Knowledge
  • Strong working knowledge of QMSR, ISO 13485, and global quality regulations.
  • Demonstrated ability to lead cross-functional teams and manage multiple workstreams.
  • Excellent technical writing, analytical, and problem-solving skills.
  • Strong interpersonal and communication skills, including the ability to provide executive-level updates and support regulatory documentation.
  • Detail-oriented, highly organized, proactive, and comfortable working in a dynamic environment.
  • Ability to present materials to director-level leadership.
  • Understanding of statistics and statistical analysis.

So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!
The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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