QA Specialist

SEKISUI Diagnostics•San Diego, CA

1d•$87,000 - $100,000•Hybrid

About The Position

The QA Specialist helps maintain and strengthen the Quality Management System in a regulated medical-device environment. The role partners across functions to ensure processes, documentation, and products meet applicable quality and regulatory requirements. Responsibilities may span deviations and CAPAs, change control, audits, validation, equipment management, quality data and trends, QMS support, and cross-functional projects with teams including R&D and Operations. The position requires onsite presence four days per week.

Requirements

Experience in a regulated environment.
Knowledge of 21 CFR Part 820, ISO 13485, and FDA medical device requirements.
Experience with deviations, CAPAs, change control, audits, equipment management, and validation.
Strong problem-solving skills, including the ability to assess nonconformities and recommend effective solutions.
Ability to manage multiple priorities and projects successfully.
Strong communication and interpersonal skills, including the ability to navigate challenging situations.
Collaborative, customer-focused approach and ability to work independently and across teams.

Nice To Haves

Five or more years of relevant Quality Assurance experience preferred.

Responsibilities

Review deviations and CAPAs from a Quality Assurance perspective.
Review and approve change requests related to controlled documentation.
Manage the equipment calibration program.
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.