Hybrid Director of Quality

at Visby Medical

• Job title: Director of Quality
• Job type: Full Time
• Experience level: Lead
• Salary: $190,000 - $230,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Cyber Security
• Location requirements: Hybrid, San Jose, United States

About the role

• Director of Quality ensuring Visby’s products meet highest standards of quality and compliance. Leading a team in a biotech startup to drive continuous improvement throughout product lifecycle.

Responsibilities

• Maintain a robust and effective QMS that is compliant with relevant regulations (e.g., FDA QSR, ISO 13485) and consensus standards.
• Serve as the company’s management representative by reporting to top management on the effectiveness of the QMS and the need for any improvements.
• Ensuring promotion and awareness of the QMS and of applicable regulatory requirements.
• Actively participate in the day-to-day QMS activities and develop an in-depth knowledge of the drivers of product quality.
• Stay abreast of changes to relevant quality system regulations and consensus standards and ensure that Visby’s QMS is appropriately updated.
• Collaborate with supply chain and subject matter experts to ensure the quality and reliability of suppliers and contractor manufacturers though the use of supplier controls.
• Ensure that effective supplier quality agreements are developed and implemented with suppliers and contractor manufacturers, including those located outside the United States.
• Ensure that risk management activities are effectively used to drive improvement to product quality throughout the product life cycle.
• Oversee software quality assurance, including software verification activities and collaborating with stakeholders to ensure implementation of cybersecurity requirements.
• Oversee an efficient and effective document control system.
• Ensure that quality audits are planned, conducted and that effective corrective actions are taken when needed.
• Serve as the company point of contact with external quality system auditors (e.g., FDA).
• Ensure effective quality system training and establish metrics to monitor training effectiveness.
• Ensure efficient and effective quality control processes and procedures, including use of appropriate sampling techniques.
• Foster a culture of quality throughout the organization by promoting awareness, accountability and continuous improvement.

Requirements

• A bachelor’s degree in engineering, life science or a related field, an advanced degree preferred.
• A minimum of 5+ years of quality system management experience, preferably in in vitro diagnostics.
• In-depth knowledge of relevant regulations and standards (e.g., FDA QSMR, ISO 13485)
• Demonstrated ability to effectively manage supplier quality.
• Experience with technology transfer and process validation in remote or outsourced manufacturing environments.
• Willingness to travel internationally as needed to support supply quality.
• Strong understanding of risk management principles and practices.
• Proven ability to work with a cross-functional team.

Benefits

• highly competitive health insurance through United Healthcare or Kaiser
• company-funded HSA option
• flexible paid time off
• 10 company holidays
• many other contemporary benefits and perks