CAPA Specialist

Novozen Healthcare LLC; Massachusetts; On-site; USD 69,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Retirement Benefits

Paid Time Off

Job summary

Novozen Healthcare LLC is seeking CAPA Specialists to support a large-scale QMS remediation initiative for a medical device organization under FDA oversight in the Boston area.

You will lead CAPA investigations, root cause analysis, and corrective/preventive actions, drive backlog reduction, and develop investigation reports with thorough documentation.

The role requires 5–10+ years in medical device quality systems, knowledge of FDA 21 CFR Part 820 and ISO 13485, and onsite work in Boston.

Qualifications

• 5–10+ years of experience in medical device quality systems.
• Hands-on CAPA investigations and root cause analysis.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with CAPA remediation, audit readiness, or quality system remediation.
• Strong technical writing and documentation skills.
• Ability to work onsite in the Boston area.

Responsibilities

• Lead and execute CAPA investigations, root cause analysis, and corrective/preventive actions.
• Drive CAPA backlog reduction and timely closure of open CAPAs.
• Develop investigation reports and maintain CAPA documentation.
• Perform effectiveness checks and ensure CAPA compliance.
• Identify gaps in quality processes and documentation.
• Collaborate with cross-functional teams to resolve quality issues.
• Support FDA audit readiness and inspection activities.

Skills

CAPA investigations

Root cause analysis

Quality systems

FDA 21 CFR Part 820 knowledge

ISO 13485 knowledge

Technical writing

Onsite work

Job description

We are seeking CAPA Specialists to support a large-scale Quality Management System (QMS) remediation initiative for a medical device organization under FDA oversight.

Responsibilities

• Lead and execute CAPA investigations, root cause analysis, and corrective/preventive actions.
• Drive CAPA backlog reduction and timely closure of open CAPAs.
• Develop investigation reports and maintain CAPA documentation.
• Perform effectiveness checks and ensure CAPA compliance.
• Identify gaps in quality processes and documentation.
• Collaborate with cross-functional teams to resolve quality issues.
• Support FDA audit readiness and inspection activities.

Requirements

• 5–10+ years of experience in medical device quality systems.
• Strong hands-on CAPA investigation and root cause analysis experience.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with CAPA remediation, audit readiness, or quality system remediation.
• Strong technical writing and documentation skills.
• Ability to work onsite in the Boston area.

Preferred Qualifications

• Experience supporting FDA inspections, warning letters, or remediation programs.
• Experience with CAPA backlog reduction and high-volume documentation remediation.

Pay Scale

Anticipated hourly pay range: 50/hr to $65/hr. (Depends on Experience)

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO)

No PTO other than that required by applicable state and local laws