Director of Quality

Visby Medical • San Jose, CA

4d • $190,000 - $230,000

About The Position

The Director of Quality plays a pivotal role in ensuring that Visby’s products meet the highest standards of quality, safety, and compliance. You will lead and participate in all aspects of the quality management system (QMS) and work closely with cross-functional teams to drive continuous improvement and maintain compliance with the QMS throughout the product lifecycle. A critical aspect is to establish and oversee supplier quality of an overseas contractor manufacturer, including supporting the design transfer process. The position requires significant international travel to conduct audits and build relationships with suppliers.

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.

Nice To Haves

• Experience with software quality assurance, including cybersecurity.
• Experience with molecular infectious disease testing.

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.

Benefits

• Visby offers highly competitive health insurance through United Healthcare or Kaiser, including a company-funded HSA option.
• We also offer flexible paid time off, 10 company holidays, and many other contemporary benefits and perks.
• Visby is a proud recipient of the 2023 Cigna Healthy Workforce Designation.

What This Job Offers

• Job Type: Full-time
• Career Level: Director