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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

quality management system (QMS)risk managementsoftware quality assurancedocument controlsupplier quality managementprocess validationtechnology transfercybersecurity requirementssampling techniquesquality audits

Soft Skills

communicationcollaborationleadershipaccountabilitycontinuous improvementtraining effectivenesscross-functional teamworkawareness promotionproblem-solvingreporting