Senior Quality Systems Specialist

Job Description

Our client is in search of a Senior Quality Systems Specialist to join their team at Asensus Surgical.

Who We Are

At Asensus, we are digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery. Our employees are especially passionate about the work they do and thrive in a collaborative environment that fosters creative solutions to complex problems. The work is challenging, but everyone comes to Asensus looking for a fulfilling career, and that's exactly what they find.

The Role

This role will be part of the Global Quality team and will be responsible for activities associated with product and processes support at Asensus globally and associated with global quality assurance and document control.

The Senior Quality Systems Specialist ensures that all activities for Quality Systems are followed and documented to provide a safe and effective product that meets customer needs, while maintaining compliance.

What You'll Do

• Ensures compliance with global Asensus quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.
• Supports Global Quality System ensuring that all activities for ISO 13485 and 21 CFR compliance are followed and documented.
• Leads CAPAs globally, coordinating the board and ensuring CAPAs resolution.
• Conducts / leads audits as appropriate (internal and external).
• Supports Third Party Audits and acts as reference person for the US site.
• Supervises document control and change support.
• Supports company training to ensure compliance with ISO 13485.
• Supports supplier management (audits, qualification, monitoring, CAPAs and associated activities).
• Supports Product Evaluation Board generating metrics and presenting quarterly evaluations of external feedback and trends.
• Supports quality metrics, dashboards and KPIs.
• Assists with risk management activities including support regarding creation and maintenance of risk management files by product and process.
• Supports complaints as needed.
• All Other Essential Duties as directed.

What You Bring

Technical Skills

What We Offer

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