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Capa Manager Jobs in Delaware (NOW HIRING)

Datwyler

Quality Assurance Engineer

Middletown, DE · On-site

This role supports manufacturing and new product introduction through risk management, process ... Implement corrective and preventive actions (CAPA) and verify effectiveness. * Drive continuous ...

Datwyler

Quality Assurance Engineer

Middletown, DE

This role supports manufacturing and new product introduction through risk management, process ... Implement corrective and preventive actions (CAPA) and verify effectiveness. * Drive continuous ...

Corteva Agriscience

Study Coordinator

Newark, DE · On-site

Coordinate with Planning & Management, Study Directors, PIs, and Technical Leads to align facility ... actions (CAPA). * Drive continuous improvement by identifying recurring pain points (e.g ...

Hologic

Quality Engineer 3

Newark, DE · On-site

$97K - $152K/yr

Responsible for planning, implementing and managing compliance of manufacturing and production ... Responsible for processes such as MRB, NCE, CAPA and SCAR process. * Responsible for the review and ...

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How much do capa manager jobs pay per hour?

As of Jun 14, 2026, the average hourly pay for capa manager in Delaware is $37.74, according to ZipRecruiter salary data. Most workers in this role earn between $28.67 and $44.48 per hour, depending on experience, location, and employer.

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 in the Capa Manager position, and why are they important?

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 Delaware? For Capa Manager jobs in Delaware, the most frequently searched job titles are:
What job categories do people searching Capa Manager jobs in Delaware look for? The top searched job categories for Capa Manager jobs in Delaware are:
What cities in Delaware are hiring for Capa Manager jobs? Cities in Delaware with the most Capa Manager job openings:
Capa Manager jobs near you

Quality Assurance Engineer

Datwyler

Middletown, DE • On-site

Full-time

Posted 9 days ago

Job description

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.
Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...
Position Summary
The Quality Engineer at Datwyler is responsible for ensuring that products, processes, and quality systems comply with internal standards, customer requirements, and applicable regulatory requirements. This role supports manufacturing and new product introduction through risk management, process validation, continuous improvement, and root cause analysis, contributing to Datwyler's commitment to patient safety and product excellence.
Essential Functions
Quality Systems & Compliance
  • Ensure compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and other applicable regulatory and customer requirements.
  • Support internal, external, customer, and regulatory audits; prepare documentation and lead follow-up activities.
  • Maintain and improve quality procedures, work instructions, and records.

Manufacturing & Process Support
  • Provide quality engineering support for manufacturing processes, including molding, assembly, inspection, and packaging.
  • Oversight process validations (IQ, OQ, PQ) and maintain validation documentation.
  • Participate in PFMEA, Control Plans, and risk management activities.
  • Support containment, investigation, and resolution of nonconformities.

Continuous Improvement
  • Oversight and support root cause investigations using tools such as 8D, Fishbone, and 5-Why.
  • Implement corrective and preventive actions (CAPA) and verify effectiveness.
  • Drive continuous improvement initiatives using Lean and Six Sigma methodologies.

New Product Introduction (NPI)
  • Support quality planning and risk assessments for new products and transfers.
  • Review customer specifications, drawings, and validation requirements.
  • Ensure quality deliverables are completed on time for project milestones.

Supplier & Customer Quality
  • Support supplier qualification, audits, and performance monitoring.
  • Investigate customer complaints and ensure timely, compliant responses.
  • Collaborate with customers to resolve quality issues and improve satisfaction.

Qualifications
Education
  • Bachelor's degree in Engineering, Quality, Science, or a related discipline.

Experience
  • 2-5+ years of quality engineering experience in a regulated manufacturing environment, preferably medical device, pharmaceutical, or healthcare packaging.
  • Experience with molding or precision manufacturing processes preferred.

Technical Skills
  • Strong knowledge of:
    • ISO 13485
    • FDA 21 CFR 820
    • Risk management (ISO 14971)
    • Process validation
  • Experience with statistical tools and SPC.
  • Proficiency in MS Office; experience with eQMS systems is a plus.

Be yourself at Datwyler
We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.
www.datwyler.com

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