Director of Quality

Virtual Incision; Lincoln (NE); In loco; USD 140.000 - 210.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental, Vision Insurance

Disability Insurance

Life Insurance

401(k)

Flexible working hours

PTO

Descrizione del lavoro

Virtual Incision is seeking a Director of Quality to lead the Quality function, ensuring the QMS is compliant, scalable, and integrated with manufacturing and business operations. The role partners with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Operations to maintain product quality and readiness for commercialization.

The Director will guide quality system activities, investigations, audits, and problem-solving to ensure timely resolution of quality and compliance issues

Competenze

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related technical discipline.
• 10+ years of progressive Quality Assurance and Quality Systems experience in regulated industry.
• 5+ years of quality leadership overseeing quality systems and team development.

Mansioni

• Lead and maintain the Quality Management System (QMS) ensuring FDA/ISO compliance.
• Oversee CAPA, complaint handling, nonconforming material control, document control, training, and audits.
• Lead investigations, root-cause analyses, corrective and preventive actions.

Conoscenze

QMS leadership

FDA/ISO knowledge

Root cause analysis

Cross-functional leadership

Problem solving

Formazione

Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related

Descrizione del lavoro

Job Title: Director of Quality Date: October 14,2026

Department: Operations Location: Onsite, Lincoln,NE

Virtual Incision is advancing robotic-assisted surgery with a focus on expanding access to minimally invasive care. We are a growing medical technology company where experienced leaders have the opportunity to make a meaningful and visibleimpact.

Why VirtualIncision:

• Work on innovative robotic surgical technology with the potential to improve patientcare.
• Join an experienced, collaborative team focused on clinical excellence and disciplined execution.
• Take meaningful ownership of products and programs in a hands-on environment.
• Work in a culture that values technical rigor, practical problem-solving, andteamwork.
• Competitive benefits including medical, dental, vision, disability and life insurance, 401(k), flexible working hours, andPTO.

Job Summary:

The Director of Quality is a highly engaged, hands-on leader responsible for the performance, effectiveness, and continuous improvement of Virtual Incision's Quality function. This role is responsible for ensuring that the Quality Management System (QMS) remains compliant, practical, scalable, and fully integrated into manufacturing and businessoperations.

The Director of Quality will work closely with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Operations teams to ensure product quality, regulatory compliance, and manufacturing readiness while supporting commercialization, production scale-up, and continuous improvement efforts. The successful candidate will be comfortable operating strategically while remaining actively involved in quality system activities, investigations, audits, and problem-solving to ensure timely resolution of quality and complianceissues.

Responsibilities:

• Lead and maintain the effectiveness of the Quality Management System (QMS), ensuring compliance with applicable FDA regulations, ISO standards, and companyprocedures.
• Ensure disciplined execution and timely closure of core quality system processes including CAPA, Complaint Handling, Nonconforming Material Control, Document Control, Training, Internal Audits, and ManagementReview.
• Review and approve Change Requests, CAPAs, complaint investigations, and nonconforming material records as appropriate.
• Provide hands-on leadership for investigations, root cause analyses, corrective actions, and preventive actions related to product, process, supplier, and quality systemissues.
• Partner closely with Manufacturing and Operations teams to ensure quality requirements are integrated into production processes and continuously improved.
• Support design transfer, product commercialization, manufacturing scale-up, and process validationactivities.
• Collaborate with Engineering teams to ensure product and process changes are implemented in a compliant and effectivemanner.
• Lead supplier quality activities, including supplier monitoring, quality performance assessment, risk management, and issueresolution.
• Ensure effective management of nonconforming materials and product disposition decisions.
• Participate in Complaint Review Board, CAPA Review Board, Material Review Board, and other quality governanceactivities.
• Monitor quality metrics, identify trends, assess risks, and drive improvements that enhance product quality and QMS effectiveness.
• Lead internal audits and support customer, certification, and regulatory audits and inspections, including preparation, execution, response, and follow-upactivities.
• Present quality records, quality metrics, and quality system performance during audits, inspections, and managementreviews.
• Partner with Regulatory Affairs to support inspections, regulatory submissions, and compliance initiatives.
• Develop and improve quality procedures, processes, metrics, and systems to support organizational growth and operational excellence.
• Foster a culture of quality, accountability, compliance, and continuous improvement throughout the organization.
• Build and develop a high-performing Quality team while establishing clear priorities, expectations, and accountability.
• Establish strong cross-functional relationships and ensure alignment between Quality, Manufacturing, Engineering, Supply Chain, and RegulatoryAffairs.
• Drive continuous improvement initiatives that improve product quality, manufacturing performance, and overall business effectiveness.

Qualifications:

Required

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technicaldiscipline.
• 10+ years of progressive Quality Assurance and Quality Systems experience within the medical device industry or another highly regulatedindustry.
• 5+ years of quality leadership experience with responsibility for quality systems, compliance, and team development.
• Demonstrated experience developing, implementing, maintaining, and improving Quality ManagementSystems.
• Strong experience with CAPA, complaint handling, internal audits, supplier quality, document control, training, and nonconforming materialmanagement.
• Experience supporting manufacturing operations, design transfer, commercialization, and operational growth initiatives.
• Experience leading customer, certification, regulatory, and internalaudits.
• Strong knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, and Good Manufacturing Practices (GMP).

Preferred

• ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or similar certification.
• Experience with robotic, electromechanical, or Class II/III medicaldevices.
• Experience in a startup, growth-stage, or rapidly scaling medical device environment.
• Experience supporting FDA inspections and international regulatoryaudits.

Knowledge, Skills &Abilities

• Strong technical expertise in medical device quality systems, compliance, and riskmanagement.
• Demonstrated ability to drive measurable improvements in product quality, operational performance, and QMS effectiveness.
• Strong root cause analysis, problem-solving, and decision-making capabilities.
• Excellent communication and cross-functional leadershipskills.
• Ability to influence stakeholders at all levels of the organization.
• Strong organizational and project managementskills.
• Ability to thrive in a dynamic, fast-paced environment while maintaining attention to detail and regulatorycompliance.

Status: Exempt

Virtual Incision is an Equal Opportunity Employer and values diversity in itsworkforce.

Disclosure and Important Safety Information

The MIRA Surgical System is intended for prescription use only. Patients should talk to their doctor to decide if surgery with a MIRA Surgical System is right for them. Patients and doctors should review all available information on nonsurgical and surgical options and associated risks in order to make an informeddecision.

Serious complications may occur in any surgery, including minimally invasive surgery with the MIRA Surgical System, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs, and/or conversion to other surgical techniques which could result in a longer operative time and/or complications.

For important safety information, including surgical risks and considerations, please also refer to www.virtualincision.com/safety-information . For the product’s indications for use, risks, full cautions, and warnings, please refer to the associated user manual(s).

Individual outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, surgeon, and/or hospitalexperience.

MIRA Surgical System PrecautionStatement

The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the MIRA Surgical System as a surgical device and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trainedsurgeon.

Contact

Virtual Incision
1501 Old CheneyRd
Lincoln, NE68512