Senior QA Specialist – Regulated Medical Devices (Onsite)

Sekisui Diagnostics, LLC; San Diego (CA); On-site; USD 87,000 - 100,000; Full time

Job summary

SEKISUI Diagnostics, LLC is seeking a QA Specialist to strengthen our Quality Management System and ensure compliance across deviations, CAPAs, change control, audits, and validations. You will partner with R&D, Operations, and cross-functional teams to drive continuous improvement and robust quality practices.

With 5+ years of QA experience in a regulated environment and knowledge of 21 CFR Part 820, ISO 13485, and FDA medical device requirements, you will help maintain compliance while

Qualifications

• 5+ years of Quality Assurance experience in a regulated environment.
• Experience with 21 CFR Part 820, ISO 13485 & FDA medical device requirements.
• Experience with deviations, CAPAs, change control, audits, equipment management, and validation.
• Strong problem-solving skills to assess nonconformities and implement effective solutions.
• Ability to manage multiple priorities and projects.
• Strong communication and interpersonal skills; ability to navigate challenging situations.
• Collaborative, customer-focused approach with ability to work independently and across teams.

Responsibilities

• Review deviations and CAPAs from a QA perspective.
• Review and approve change requests related to controlled documentation.
• Plan and perform internal compliance audits.
• Participate in or conduct external supplier audits.
• Review and approve validation protocols and summary reports.
• Generate and analyze quality data and trends to identify opportunities for improvement.
• Maintain and support the QMS (CATSWeb).
• Provide QA support and oversight to cross-functional project teams, including R&D and Operations.
• Partner with colleagues to address quality concerns and maintain compliance with established requirements.

Skills

Quality Assurance

Regulated environment

Problem solving

Communication

Collaboration

Tools

CATSWeb

Job description

SEKISUI Diagnostics, LLC is seeking a QA Specialist to strengthen our Quality Management System and ensure compliance across deviations, CAPAs, change control, audits, and validations. You will partner with R&D, Operations, and cross-functional teams to drive continuous improvement and robust quality practices.

With 5+ years of QA experience in a regulated environment and knowledge of 21 CFR Part 820, ISO 13485, and FDA medical device requirements, you will help maintain compliance while