Quality & CAPA Manager

Sun IP; United States; Remote; USD 45,000 - 112,000; Full time

Job summary

Sun IP seeks a Quality & CAPA Manager to enhance quality management systems and ensure compliance with regulations. This remote role includes overseeing audits, managing CAPA processes, and promoting continuous improvement. Ideal candidates will demonstrate strong analytical and communication skills.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Experience in quality management systems.
• Ability to conduct audits and inspections.
• Skilled in training employees on quality policies.

Responsibilities

• Oversee compliance with quality systems and regulations.
• Lead the CAPA process from identification to implementation.
• Drive quality improvement initiatives across operations.

Skills

Root cause analysis

Corrective action methodologies

Communication

Organizational skills

Leadership

Job description

Sun IP’s industry-leading patent translation, foreign filing, patent and trademark renewals, and annuity solutions empower intellectual property professionals to seamlessly protect innovation around the globe.

The Quality & CAPA Manager is responsible for overseeing the organization's quality systems and leading the Corrective and Preventive Action (CAPA) process. This role ensures compliance with internal standards and external regulations, drives root cause investigations, and fosters continuous improvement across operations. The manager will maintain and enhance the quality management process, support audits, and promote a strong culture of quality throughout the organization.

This is a remote position. Candidates must be able to work in either Eastern Standard Time or Central Standard Time. Candidates currently residing in Canada will be considered as well.

Key Responsibilities:

-Quality Management

• Monitor key quality metrics (e.g., defect rates, audit findings, customer complaints) and lead data-driven improvement initiatives.
• Manage internal and external audits, including regulatory inspections.
• Ensure ongoing compliance with customer requirements, industry regulations, and company policies.
• Train employees on quality policies, SOPs, and regulatory expectations.

-CAPA Management

• Own and manage the end-to-end CAPA process, from issue identification and investigation through implementation and effectiveness verification.
• Facilitate cross-functional root cause analysis to identify systemic issues.
• Ensure timely completion of CAPAs, tracking progress, and escalating delays as necessary.
• Maintain CAPA documentation and records in compliance with quality standards and audit requirements.
• Analyze CAPA trends to proactively identify recurring issues and implement preventive measures.

-Process Improvement & Risk Management

• Collaborate with various departments to reduce process variability and improve product quality.
• Lead quality improvement initiatives.

Qualifications:

• Proficient in root cause analysis and corrective action methodologies.
• Excellent communication, organizational, and leadership skills.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Management

• Industries

  Legal Services and Translation and Localization

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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