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Assistant Capa Engineer Jobs (NOW HIRING)

Beacon Engineering Resources

Quality Engineer

Boston, MA · On-site

$78K - $101K/yr

Perform internal audits and assist with maintaining compliance to quality management system ... Lead and support Root Cause Analysis and Corrective and Preventive Action (CAPA) activities.

Pinnaql

Compliance Engineer

Juncos, PR · On-site

This role is responsible for supporting investigations, CAPA activities, change management ... * Assist with onboarding coordination activities, forms, access requests, and related compliance ...

Pinnaql

Compliance Engineer

Gurabo, PR · On-site

This role is responsible for supporting investigations, CAPA activities, change management ... * Assist with onboarding coordination activities, forms, access requests, and related compliance ...

Veg Group

Compliance Engineer

Gurabo, PR · On-site

$70 - $90/hr

This role is responsible for supporting investigations, CAPA activities, change management ... * Assist with onboarding coordination activities, forms, access requests, and related compliance ...

New

Pinnaql

Compliance Engineer

Punta Santiago, PR · On-site

This role is responsible for supporting investigations, CAPA activities, change management ... * Assist with onboarding coordination activities, forms, access requests, and related compliance ...

Pinnaql

Compliance Engineer

Humacao, PR · On-site

This role is responsible for supporting investigations, CAPA activities, change management ... * Assist with onboarding coordination activities, forms, access requests, and related compliance ...

Pinnaql

Compliance Engineer

Humacao, PR · On-site

This role is responsible for supporting investigations, CAPA activities, change management ... * Assist with onboarding coordination activities, forms, access requests, and related compliance ...

Veg Group

Compliance Engineer

Juncos, PR · On-site

$70 - $90/hr

This role is responsible for supporting investigations, CAPA activities, change management ... * Assist with onboarding coordination activities, forms, access requests, and related compliance ...

New

Winston Industries LLC

Quality Engineer

Louisville, KY · On-site

$69K - $89K/yr

Experience with CAPA systems. * ASQ Certified Quality Engineer (CQE) or willingness to pursue ... Collaborate with Purchasing and Engineering to improve supplier performance. * Assist with incoming ...

Winston Industries LLC

Quality Engineer

Louisville, KY · On-site

$69K - $89K/yr

Experience with CAPA systems. * ASQ Certified Quality Engineer (CQE) or willingness to pursue ... Collaborate with Purchasing and Engineering to improve supplier performance. * Assist with incoming ...

Winston Industries LLC

Quality Engineer

Louisville, KY · On-site

$65K - $85K/yr

Experience with CAPA systems. * ASQ Certified Quality Engineer (CQE) or willingness to pursue ... Collaborate with Purchasing and Engineering to improve supplier performance. * Assist with incoming ...

Winston Industries LLC

$85 - $110/hr

Experience with CAPA systems. * ASQ Certified Quality Engineer (CQE) or willingness to pursue ... Collaborate with Purchasing and Engineering to improve supplier performance. * Assist with incoming ...

New

Winston Industries LLC

Quality Engineer

Louisville, KY · On-site

$85 - $110/hr

Experience with CAPA systems. * ASQ Certified Quality Engineer (CQE) or willingness to pursue ... Collaborate with Purchasing and Engineering to improve supplier performance. * Assist with incoming ...

Ambu

Quality Engineer

Noblesville, IN · On-site

$67K - $87K/yr

... * Assist in the improvement and streamlining of quality practices across the organization to ... Participate in CAPA Review Board (CRB) meetings, as necessary. * Review calibrations out of ...

aspensurgical

Quality Engineer (NY)

Jamaica, NY · On-site

$75K - $97K/yr

This role is responsible for complaints management, CAPA, change control, and supplier quality ... * Assist with validation and verification activities as required Supplier Quality Management

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Assistant Capa Engineer information

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$33K

$88.8K

$134.5K

How much do assistant capa engineer jobs pay per year?

As of Aug 21, 2026, the average yearly pay for assistant capa engineer in the United States is $88,754.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,500.00 and $104,500.00 per year, depending on experience, location, and employer.

What is an Assistant CAPA engineer?

Assistant CAPA (Corrective and Preventive Action) Engineers are entry- to mid-level professionals who support the implementation and management of CAPA processes within organizations, particularly in regulated industries like pharmaceuticals, medical devices, or manufacturing. Their main responsibilities include investigating quality-related issues, collecting and analyzing data, and helping to develop solutions that prevent recurrence of problems. They work closely with quality assurance teams to ensure compliance with industry standards and regulatory requirements. Assistant CAPA Engineers also help document CAPA activities and monitor the effectiveness of implemented solutions.

How does an Assistant CAPA engineer typically collaborate with other departments during the corrective and preventive action (CAPA) process?

An Assistant CAPA Engineer frequently works alongside quality assurance, manufacturing, and regulatory teams to investigate root causes of non-conformances and implement effective corrective and preventive actions. This collaboration often involves gathering input from cross-functional teams, reviewing documentation, and participating in meetings to ensure that CAPA solutions are thorough and compliant with industry standards. Effective communication and teamwork are essential, as the Assistant CAPA Engineer must coordinate updates, track progress, and help ensure timely closure of CAPA items.

What are the key skills and qualifications needed to thrive as an Assistant CAPA engineer, and why are they important?

To thrive as an Assistant CAPA Engineer, you need a solid understanding of quality management systems, root cause analysis, and regulatory compliance, generally supported by a degree in engineering or a related field. Familiarity with tools like CAPA software, Six Sigma methodologies, and ISO 13485 standards is typically required. Strong attention to detail, problem-solving skills, and effective communication are vital soft skills for this role. These competencies ensure effective corrective and preventive actions, regulatory compliance, and continuous improvement within quality-driven industries.

What is the difference between Assistant Capa Engineer vs Quality Control Engineer?

AspectAssistant Capa EngineerQuality Control Engineer
Required CredentialsEngineering degree, training in CAPA processesEngineering or science degree, QC certifications often preferred
Work EnvironmentManufacturing, pharmaceutical, or medical device industriesManufacturing, pharmaceutical, or food industries
Employer & Industry UsageUsed in industries focusing on corrective actions and complianceFocuses on product quality, testing, and inspection

The Assistant Capa Engineer primarily supports the implementation of Corrective and Preventive Actions (CAPA) to address quality issues, while the Quality Control Engineer focuses on testing and inspecting products to ensure quality standards. Both roles are essential in manufacturing and regulated industries, but they differ in their core responsibilities and focus areas.

What cities are hiring for Assistant Capa Engineer jobs?

Cities with the most Assistant Capa Engineer job openings:

What are the most commonly searched types of Capa Engineer jobs?

The most popular types of Capa Engineer jobs are:

What states have the most Assistant Capa Engineer jobs?

States with the most job openings for Assistant Capa Engineer jobs include:

Assistant Capa Engineer jobs near you

Senior Design Quality Engineer

Circadia Health

El Segundo, CA • On-site

$120K - $160K/yr

Full-time

Medical, Dental, Vision, Retirement

Posted 14 days ago

Job description

About Circadia Health
Circadia Health is a growth-stage healthcare AI company on a mission to prevent avoidable hospitalizations and transform senior-care operations. Our Circadia Intelligence Platform combines:
  • Contactless sensing that monitors respiration and motion with medical-grade accuracy
  • Native predictive models that detect 85% of preventable adverse events several days in advance
  • Enterprise integrations that operationalize predictions directly inside EHR, care-coordination, billing, and compliance workflows

Today, our technology touches 40,000+ post-acute patients daily across skilled-nursing, home-health, and home-care networks. We are backed by leading healthcare and AI investors and headquartered in El Segundo, CA.
About the Role
Circadia Health is looking for a Senior Design Quality Engineer to establish and lead our quality engineering processes from the ground up. In this role, you will build, implement, and scale our Quality Management System (QMS) in alignment with ISO 13485 and FDA QMSR. You will take full ownership of design controls across the product lifecycle, establish robust complaint handling and CAPA workflows, and lead post-market surveillance activities. This role requires a hands-on, startup-savvy engineer who thrives in fast-paced environments.
Responsibilities
QMS Building & Implementation
  • QMS Architecture: Lead the design, implementation, and roll-out of an ISO 13485-compliant Quality Management System.
  • Process Creation: Establish and standardize core quality procedures, including document control, change management, CAPA, nonconformance, and audit readiness.
  • Compliance Standards: Ensure organizational alignment with ISO 13485 and prepare the company for FDA Inspections/Notified Body audits.

Post-Market Surveillance, Complaints & CAPA
  • Complaint Handling: Establish and execute end-to-end complaint handling processes, root-cause investigations, and medical device reporting (MDR) evaluations.
  • CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions.
  • Post-Market Surveillance (PMS): Design and maintain the Post-Market Surveillance (PMS) system, generating PMS reports, clinical evaluation updates, and data trending summaries.

Design Controls & Product Development Support
  • Support execution and maintenance of design control activities across the product lifecycle.
  • Maintain Design History File (DHF) documentation for Circadia products.
  • Assist with preparation and review of:
    • Design inputs and outputs
    • Risk management documentation
    • Verification and validation documentation
    • Design review records
  • Track design control deliverables and coordinate documentation across teams.

Regulatory Submission Support
  • Assist in preparation of FDA submission documentation (e.g., 510(k)).
  • Support compilation and organization of testing documentation and reports.
  • Track submission deliverables and supporting evidence.

Cross-Functional Collaboration
  • Coordinate with R&D, Engineering, Customer Success, Ops and Clinical teams to collect documentation and evidence.
  • Support human factors validation and cybersecurity testing coordination.
  • Assist with third-party testing documentation collection.

Qualifications
  • Education: Bachelor's degree in Biomedical Engineering, Software Engineering, Mechanical Engineering, or a related technical field.
  • Senior-Level Expertise: 5+ years of design quality engineering experience within the medical device or digital health industry.
  • Startup Track Record: Proven experience in a fast-paced environment where you built processes from scratch rather than executing existing ones, and are comfortable owning ambiguous, evolving work.
  • QMS Implementation: Direct experience building and implementing an ISO 13485 QMS
  • Subject Matter Ownership: Deep, hands-on proficiency in Design Controls, Risk Management (ISO 14971), CAPA management, Complaint Handling, and Post-Market Surveillance (PMS).

Nice to Have
  • QMSR Familiarity: Direct experience or working knowledge of the FDA's updated Quality Management System Regulation (QMSR).
  • Digital Health / Hardware + Software: Experience with Software as a Medical Device (SaMD) and/or software in a medical device (SiMD), firmware/hardware integration, human factors validation, and cybersecurity.
  • Regulatory Submissions: Direct involvement in successful FDA submissions or European CE mark technical files.
  • Certifications: ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Green/Black Belt.

$120,000 - $160,000 a year
As a full-time Senior Design Quality Engineer, you will be employed by Circadia Health, Inc. The anticipated annual base salary range for this full-time position is $120,000 - $160,000. The base range is determined by role and level, and placement within the range will depend on a number of job-related factors, including but not limited to your skills, qualifications, experience, and location.
Annual salary is only one part of an employee's total compensation package at Circadia Health. We also offer:
  • Meaningful employee stock options
  • 100% company-paid medical, dental, and vision coverage
  • 401(k)
  • Competitive time off with pay policies including vacation, sick days, and company holidays
  • Impact: your work will influence care decisions for tens of thousands of seniors every day.
  • Culture: hard-working, mission-driven, and collaborative - with weekly and monthly social events like yoga, beach bonfires, and Wednesday/Friday team lunches.

Circadia Health is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other status protected by law.
Circadia Health is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other status protected by law.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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