Manager, Quality Assurance

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required.

POSITION SUMMARY:

 

The Manager, Quality provides direct management to technical and managerial staff. The role contributes to the definition of the strategy and determines the tactics required to achieve business unit/function objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; the Manager, Quality ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. Success is measured in terms of the frequency and scale of product quality organizational issues as well as business process effectiveness. Through stakeholder engagement and people development, the Manager, Quality produces durable and industry leading results supporting key business drivers.

 

PRIMARY RESPONSIBILITIES:

• Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions.
• Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.
• Manage and lead Quality team for CLIA/IVD businesses. Provides leadership and direction directly or through teams as appropriate.
• Responsible for developing, managing, maintaining, reporting, and improving quality metrics. Evaluate metrics to determine if quality problems exist and set the appropriate action and escalation.
• Provide effective Quality Management leadership to department staff in order to meet quality, business, and organizational objectives.
• Assess and build organizational capability for Quality. 
• Drive a culture of compliance within the team and cross functionally utilizing Natera Values.
• Evaluate, implement. and continuously improve execution of Quality Systems and business processes, including product controls to achieve quality goals and maintain Regulatory Compliance.
• Responsible for leading quality team in the management of quality activities for Natera including CAPA, Deviations/Nonconformances, Internal/External Audits, Supplier Audits, Post-Market Surveillance, Complaint Investigations, etc.  This includes compliance to applicable regulations and standards for medical devices, in vitro diagnostics, biologics or companion diagnostics.
• Responsible for all aspects of the Post Market Surveillance program including but not limited to maintaining and implementing processes for complaint handling, serious adverse event/vigilance reporting, data analysis, trending, and review of risk documentation.
• Act as Subject Matter Expert (SME) in the quality processes in the area of responsibility.
• Mentor and develop personnel, including dedicated succession planning and contingency management. Ensure CAPA’s are implemented effectively and timely with a focus on reduction of customer complaints, non-conformances, rejections, and scrap.

• Assist on identification of root cause of quality problems in Operations, Manufacturing or customer complaints.

• Provide support and direction for new products, processes and Engineering Changes.
• Oversee the product release to ensure that safe and effective product is distributed to customers.  Responsible for approval or rejection of components, finished products, and documents to achieve this purpose. 
• May act as “management representative” for notified bodies and liaison with regulatory authorities and customers, by hosting and managing related audits and ensuring effective resolution.
• Document, review, and approve quality system documentations.

• Working knowledge of CAP/CLIA, ISO 13485 and FDA, EU, ROW (rest of world) LDT and medical diagnostic requirements.

• Direct Quality Assurance projects through the Leadership Team to sustain regulatory compliance and support company goals/continuous improvement efforts.
• Assure that all quality department associates are trained to adequately perform their assigned quality responsibilities.
• Comply with all local, state, and federal safety regulations, policies, and procedures including, if needed, Hazardous waste or safety regulations.
• Comply with all quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Other duties as assigned.
• This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in o