CAPA Specialist

Ferris Mfg. Corp.; Fort Worth (TX); On-site; USD 75,000 - 90,000; Full time

Job summary

A medical device manufacturer in Fort Worth is seeking a CAPA Specialist. The role involves leading investigations on quality issues, implementing corrective actions, and ensuring compliance with regulations. Candidates should have a BS in Science or Engineering, 4+ years in the medical device industry, and strong communication skills. This position offers a chance to improve quality management within a growing company committed to product safety and quality.

Qualifications

• 4+ years of experience in the medical device or related industry.
• 2+ years of direct CAPA experience.
• Work experience in manufacturing and quality assurance environments.

Responsibilities

• Lead investigations of quality issues and implement CAPAs.
• Evaluate quality data and initiate action plans for emerging issues.
• Participate in internal and external audits.

Skills

Problem analysis

Excellent verbal communication

Organizational skills

Detail-oriented

Education

BS in Science or Engineering

MS, MBA or advanced degree

Tools

Microsoft Word

Microsoft Excel

Job description

Ferris Mfg. Corp., a Fort Worth-based medical device manufacturer and creator of PolyMem Advanced Wound Care Dressings, is seeking a CAPA Specialist.

Support and execute the Quality and Regulatory functions at Ferris Mfg. Corp., ensuring compliance with internal policies and applicable global standards. Partner with internal departments and customers to uphold quality requirements, while maintaining proactive and responsive communication with regulatory agencies.

Investigate root causes, implement corrective and preventive actions (CAPA), and ensure compliance with regulatory requirements to prevent recurrence and maintain product safety and quality. Key responsibilities include supporting Top Management and the Regulatory Compliance Manager, managing documentation and traceability, planning and coordinating projects, monitoring product and process reviews, and delivering training programs.

Key Responsibilities

CAPAs – Lead the investigations of quality issues, identifies root causes, and drives effective corrective and preventive actions to permanently eliminate root causes, ensure product and process compliance. Partner with cross‑functional teams to implement sustainable quality improvements and maintain alignment with regulatory and internal quality system requirements.

• Evaluate quality data to spot emerging issues and initiate action plans.
• Apply appropriate conceptual methods to investigate and solve problems (history, 5 Whys, fishbone diagrams, etc.)
• Track progress of assigned actions to ensure timely and complete closure.
• Coordinate cross‑functional efforts to resolve process or product‑related problems.
• Prepare clear documentation that supports audits and regulatory inspections.
• Recommend system or process enhancements that strengthen overall quality performance.

eQMS & Systems Administration

• Serve as a backup System Administrator for MasterControl.
• Facilitate cross-departmental implementation, training, and adoption of eQMS modules.

Auditing

• Participate in internal and external audits.

Quality Events Coordination

• Track NCRs, complaints, and CAPAs.
• Collaborate on the annual Quality Plan and author quality documentation.

Skills & Qualifications

• BS in Science or Engineering required; MS, MBA, or advanced degree preferred.
• 4+ years of experience in the medical device or related industry.
• 2+ years of direct CAPA experience.
• Work experience in manufacturing and quality assurance environments.
• Strong overall administrative and organizational skills, with the ability to effectively manage personal and team responsibilities.
• Excellent verbal, written, and interpersonal communication skills.
• Proven ability to prioritize workload and manage multiple tasks efficiently.
• Methodical and detail-oriented approach to all aspects of work.
• Diligent in following up on open items and ensuring timely resolution.
• Strong problem analysis and critical thinking skills.
• Proficient in office automation software, including Microsoft Word, Microsoft Excel, email platforms, websites, and databases; ability to quickly learn company-specific systems and tools.
• Advanced Microsoft Word document formatting, editing, and proofreading skills