Director of Quality

Visby Medical, Inc.; San Jose (CA); In loco; USD 200.000 - 230.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

HSA option

Paid time off

Holidays

Descrizione del lavoro

Visby Medical, Inc. is seeking a Director of Quality to lead the quality organization and own a lean, scalable QMS for an early-stage diagnostics company.

You will oversee a team of quality engineers, software quality engineers, and document control specialists, and serve as Visby's QMS representative with FDA and auditors. The role emphasizes risk-based quality improvements and cross-functional collaboration.

Competenze

• Bachelor’s degree in engineering, life science or related field.
• 10+ years in medical device or IVD quality.
• 5+ years managing and developing quality teams.
• Experience hosting FDA inspections and registrar audits.
• In-depth knowledge of FDA QMSR and ISO 13485.

Mansioni

• Lead and develop a high-performing quality team with clear goals and growth paths.
• Maintain a QMS compliant with FDA QMSR and ISO 13485 sized to Visby’s stage.
• Streamline QMS processes using risk-based approaches.
• Evaluate eQMS and digital tools to improve efficiency.
• Oversee product, supplier and software quality and compliance.

Conoscenze

Leadership

Regulatory knowledge

Quality management

Auditing

Formazione

Bachelor’s degree in engineering or life sciences

Advanced degree preferred

Strumenti

eQMS

Descrizione del lavoro

About Visby

Visby Medical is an ambitious, well-funded, and fast-paced early-stage in vitro diagnostics company. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Visby has developed a novel diagnostic device platform that aims to redefine the way infectious disease is tested and treated.

$200,000 - $230,000 a year

About the Job

The Director of Quality will lead and develop Visby's quality organization and own a quality management system that is fully compliant and also lean, practical, and scaled to an early-stage company. You’ll lead and grow an established team and key stakeholders to ensure the QMS is both effective and efficient. You’ll serve as Visby's quality management representative with FDA and other auditors.

Responsibilities

Leadership

• Lead, develop, and retain a high-performing team of quality engineers, software quality engineers, and document control specialists, with clear goals, regular coaching, and growth paths.
• Evolve the team's structure and staffing plan to meet company objectives.
• Build quality capability across the company, so quality is shared by every function.
• Act as a servant leader by actively participating in the day-to-day QMS activities and develop an in-depth knowledge of the key drivers of product quality across the organization.

Effective and Efficient QMS

• Maintain a QMS compliant with FDA QMSR, ISO 13485, and applicable consensus standards, sized to Visby's stage, risk profile, and growth.
• Continually streamline and improve the effectiveness of the QMS while maintaining compliance and focusing the product quality.
• Use risk-based approaches to decide where rigor is needed and where a lighter process is enough.
• Evaluate and implement eQMS and other digital tools (including AI) that improve efficiency.
• Ensure that risk management activities are effectively implemented throughout the product lifecycle and used to drive product quality improvements.

Product, Supplier and Software Quality

• Collaborate with supply chain and subject matter experts to ensure the quality and reliability of suppliers and contractor manufacturers through supplier controls.
• Oversee software quality assurance, including software verification activities and collaborating with stakeholders to ensure implementation of cybersecurity requirements.

Compliance and Audits

• Serve as the company’s quality system management representative and serve as the company point of contact with external quality system auditors (e.g., FDA)
• Ensure that quality audits are planned, conducted and that effective corrective actions are taken when needed.

How Your Position will impact product quality and achievement of the quality objectives

You will provide the strategic framework and governance necessary to embed quality in every stage of the product lifecycle. By aligning quality objectives with business goals you will foster a data-driven culture of continuous improvement and ensure that every shipped product meets the specifications and customer expectations.

On Your First Day We’d Like You to Have

• A bachelor’s degree in engineering, life science or a related field, an advanced degree preferred.
• 10+ in medical device or IVD quality, including 5+ years managing and developing quality teams.
• Experience improving the efficiency and effectiveness of a QMS.
• Direct experience hosting FDA inspections and/or registrar audits with successful outcomes.
• In-depth knowledge of relevant regulations and standards (e.g., FDA QMSR, ISO 13485)
• Proven ability to effectively work with and lead cross-functional team.

It’s Great If You Have

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

More About the Team

You will lead a team of experienced quality professionals, including quality engineers, software quality engineers, and document control specialists. The team works c

More about our 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.

Additional information

We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition,genetic information, marital status, or military or veteran status.

FullCOVID VaccinationRequired

Reasonable accommodations for medical or religious reasons considered.