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Capa Engineer Jobs in Exton, PA (NOW HIRING)

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

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

Posted today

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)

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)

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 ...

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 ...

Quality Engineer

North Wales, PA · On-site

$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)

The SMT P rocess Engineer serves as the technical lead for Surface Mount Technology (SMT ... Experience with Root Cause Corrective Action (RCCA), CAPA, SPC, Lean Manufacturing, and continuous ...

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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 Aug 14, 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 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 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 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:

Infographic showing various Capa Engineer job openings in Exton, PA as of August 2026, with employment types broken down into 92% Full Time, 2% Part Time, and 6% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution, with an average salary of $98,206 per year, or $47.2 per hour.

Manufacturing Quality Engineer

Drummond Scientific Company

Broomall, PA • On-site

$71K - $92K/yr

Full-time

Posted 7 days ago


Job description

Description:

Scope of Position:

This role focuses on product quality and process integrity across the manufacturing lifecycle, supporting

both new product development and ongoing production. The Manufacturing Quality Engineer ensures

that all products are designed, manufactured, and distributed in compliance with regulatory and

customer requirements.


Key Responsibilities:

  • Maintain and improve the Quality Management System (QMS) in alignment with ISO 13485, FDA QSR, and internal procedures.
  • Process mapping, FMEAs, and statistical assessments
  • Support production teams in resolving quality issues, identifying root causes, and implementing corrective and preventive actions.
  • Evaluate, monitor, and improve manufacturing processes using statistical tools (SPC, DOE, MSA) to support data-driven decision-making.
  • Lead and support audits (internal & external), and regulatory inspections.
  • Analyze existing inspection plans, sampling plans, and quality control documentation. Make improvements where necessary.
  • Assist Business Development and Engineering teams in developing inspection and sampling plans for new products.
  • Participate in design reviews, ensuring compliance with Design Development requirements.
  • Support verification and validation (V&V) activities, including test method validation.
  • Assist with evaluation of suppliers; maintain supplier performance metrics.
  • Drive supplier corrective actions and continuous improvement initiatives.
  • Analyze quality data to identify trends, process capability, and improvement opportunities.
  • Use Excel for statistical analysis.
  • Assist with quality system elements such as CAPA, NCRs, complaint handling, and document control.
  • Prepare quality reports for management, including KPIs, audit findings, and CAPA status.
Requirements:

Qualifications:

  • Bachelor’s degree in engineering (Mechanical, Biomedical, Industrial, or related field).
  • Experience working in a regulated manufacturing environment.
  • Experience with CAPA, root cause analysis tools (5 Whys, Fishbone), and process validation (IQ/OQ/PQ).
  • Proficiency with statistical analysis and quality tools.

Desired Skills & Abilities:

  • Strong analytical and problem-solving skills.
  • Working knowledge in a regulated manufacturing environment.
  • Familiar with GDT and tolerancing analysis.
  • Ability to interpret engineering drawings and specifications.
  • Excellent communication and cross-functional collaboration.
  • Detail-oriented mindset with a commitment to product safety and compliance.
  • ASQ certifications (CQE, CQA) are a plus.
  • Ability to manage multiple priorities in a fast-paced environment.