Job Description

Project Details

• 6-Month contract. (Extension/Conversion likely).
• On-site, 5 days per week. (40 hours).

Key Responsibilities:

• Oversee core quality functions: CAPA, change control, audits, training, and complaints.
• Manage and develop quality team members.
• Act as the Quality Management Representative, reporting on QMS performance and promoting regulatory awareness.
• Ensure audit readiness and lead interactions with regulatory bodies.
• Maintain and improve quality procedures and documentation.

Qualifications:

• 5+ years of quality experience in medical devices.
• Strong understanding of ISO 13485, 21 CFR Part 820, ISO 14971; MDSAP and MDR knowledge a plus.
• Experienced in eQMS tools and audit processes.
• ISO 13485 Lead Auditor certification required; ASQ certifications preferred.

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