Job Description

We are seeking a detail-oriented and proactive Quality Systems Specialist to support our Quality Assurance team. This temporary, full-time position will be responsible for managing key quality system processes, ensuring compliance with ISO 13485 standards, and contributing to continuous improvement initiatives. The ideal candidate will have experience in medical device quality management and CAPA processes.

Key Responsibilities:

• Perform CAPA (Corrective and Preventive Action) checklists and ensure compliance.
• Send CAPA reminders and track follow-ups.
• Maintain accurate tracking of action items and meeting minutes.
• Gather and analyze Quality Indices data trends to support decision-making.
• Initiate ACAR (Action Corrective Action Request) and PCAR (Preventive Corrective Action Request) proposals.
• Complete assigned tasks related to quality system improvements and compliance.

Required Skills & Qualifications:

• Quality Experience: Minimum experience working with ISO 13485 in the medical device industry.
• CAPA Expertise: Strong understanding of Corrective and Preventive Action (CAPA) processes , including root cause investigation.
• Attention to Detail: Ability to track and manage multiple action items effectively.
• Data Analysis: Experience gathering and analyzing quality trends.
• Process Improvement: Ability to support the continuous enhancement of quality system processes.

Preferred Qualifications:

• Internal Audit Experience: While not required, candidates with experience conducting internal audits will be highly preferred.

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