Senior Quality Assurance Specialist

Position: Senior Quality Assurance Specialist at Myant
Join Myant as a Senior Quality Assurance Specialist and elevate quality standards in medical devices. Focus on compliance and risk management while enhancing health technology solutions in a regulated environment.

This senior role is pivotal for strengthening the Quality Management System (QMS) 'll ensure adherence to global ISO standards while managing design control processes for Software as a Medical Device (SaMD) products. Your impact extends across Engineering and Operations teams to ensure our products consistently meet safety and quality benchmarks.

Key Responsibilities:

• Ensure QMS compliance with ISO, MDSAP, and FDA

• Conduct risk management aligned with ISO 14971

• Manage design control processes for SaMD products

• Oversee validation and quality governance strategies

• Lead CAPA initiatives and nonconformance management

Requirements:

• Bachelor’s degree in a relevant technical field

• Minimum 7 years of quality assurance experience

• In-depth knowledge of regulatory compliance standards

• Experience leading audits and inspections

• Solid collaboration and communication skills

Drive quality assurance excellence and make a significant impact on healthcare technology development at Myant.
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