Director of Supplier Quality
Visby Camera Corporation, San Jose, CA, United States
About the Job
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.
How You’ll Make an Impact The Director of Quality leads a team of quality professionals and fosters a culture of continuous improvement and collaboration within the organization to ensure Visby’s products meet quality, safety and compliance standards.
How Your Position will Impact Product Quality and Achievement of the Quality Objectives You will provide the strategic framework and governance 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 specifications and customer expectations.
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 improvements.
Promote awareness of the QMS and applicable regulatory requirements.
Actively participate in day-to-day QMS activities and develop in-depth knowledge of drivers of product quality.
Stay abreast of changes to relevant quality system regulations and consensus standards and ensure Visby’s QMS is updated.
Collaborate with supply chain and subject matter experts to ensure supplier and contractor manufacturer quality and reliability through supplier controls.
Develop and implement effective supplier quality agreements with suppliers and contractor manufacturers, including those located outside the United States.
Ensure risk management activities are used to drive product quality improvements throughout the product lifecycle.
Oversee software quality assurance, including software verification activities and cybersecurity requirements.
Oversee an efficient and effective document control system.
Plan and conduct quality audits and ensure effective corrective actions when needed.
Serve as the company point of contact with external quality system auditors (e.g., FDA) and establish training metrics to monitor training effectiveness.
Ensure efficient and effective quality control processes and procedures, including appropriate sampling techniques.
Foster a culture of quality through awareness, accountability and continuous improvement.
On Your First Day We’d Like You to Have
Bachelor’s degree in engineering, life science or a related field; 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 manage supplier quality and 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.
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 quality professionals, including quality engineers, software quality engineers, and document control specialists. The team works collaboratively to ensure compliance with the quality system while meeting business objectives.
Benefits Visby offers highly competitive health insurance through UnitedHealthcare 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.
Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.
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How You’ll Make an Impact The Director of Quality leads a team of quality professionals and fosters a culture of continuous improvement and collaboration within the organization to ensure Visby’s products meet quality, safety and compliance standards.
How Your Position will Impact Product Quality and Achievement of the Quality Objectives You will provide the strategic framework and governance 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 specifications and customer expectations.
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 improvements.
Promote awareness of the QMS and applicable regulatory requirements.
Actively participate in day-to-day QMS activities and develop in-depth knowledge of drivers of product quality.
Stay abreast of changes to relevant quality system regulations and consensus standards and ensure Visby’s QMS is updated.
Collaborate with supply chain and subject matter experts to ensure supplier and contractor manufacturer quality and reliability through supplier controls.
Develop and implement effective supplier quality agreements with suppliers and contractor manufacturers, including those located outside the United States.
Ensure risk management activities are used to drive product quality improvements throughout the product lifecycle.
Oversee software quality assurance, including software verification activities and cybersecurity requirements.
Oversee an efficient and effective document control system.
Plan and conduct quality audits and ensure effective corrective actions when needed.
Serve as the company point of contact with external quality system auditors (e.g., FDA) and establish training metrics to monitor training effectiveness.
Ensure efficient and effective quality control processes and procedures, including appropriate sampling techniques.
Foster a culture of quality through awareness, accountability and continuous improvement.
On Your First Day We’d Like You to Have
Bachelor’s degree in engineering, life science or a related field; 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 manage supplier quality and 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.
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 quality professionals, including quality engineers, software quality engineers, and document control specialists. The team works collaboratively to ensure compliance with the quality system while meeting business objectives.
Benefits Visby offers highly competitive health insurance through UnitedHealthcare 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.
Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.
#J-18808-Ljbffr