Quality Engineering Manager

Overview:

Kuros Biosciences, Inc. is seeking a Quality Engineering Manager to join our core operations team to support the build out and running of Kuros’ newest manufacturing facility in Alpharetta, Georgia. The Quality Engineering Manager owns the execution of Quality operational goals as well as directing, organizing, and controlling all Quality activities and teams. This role establishes the path and leads resources to ensure continuous quality and manufacturing improvements. Critical success factors for this role include leadership, developing people, optimizing resource output and enforcing quality standards. The manager is responsible for ensuring alignment with applicable US regulations (e.g., FDA, ISO 13485) and company-wide quality goals.

Key Responsibilities:

• Once the facility is completed, establish, lead and manage Kuros’ US Quality Engineering and Quality Control team and support the Global Quality team by leading by example and providing guidance across the Quality team to embed and sustain a culture of safety-first mentality, lean manufacturing, continuous improvement, awareness, inquisitiveness, persistence around processes and product quality improvements.
• With the support of the VP Quality & Regulatory and in consultation with the VP of US Operations, develop Quality departmental strategy and vision to ensure adherence with customer expectations, enforce consistent and continual improvements, and monitor Quality metrics
• Ensure compliance with applicable regulatory standards (e.g., FDA, ISO 13485)
• Oversee deviations, trends and manage CAPA investigations, root cause analyses, and effectiveness checks
• Lead and support audits (internal (at both manufacturing facilities), external, regulatory) and ensure timely closure of findings
• Collaborate with R&D, Manufacturing, and Supply Chain teams to ensure product and process quality
• Analyze quality trends and performance data; implement corrective and preventive actions as needed
• Lead quality planning for new product introductions and process validations (IQ/OQ/PQ)
• With the support of the Global Quality team, oversee design control, risk management, and product lifecycle quality activities
• With the utilization of our lean methodologies such as morning markets, manage communications between value streams to ensure Operations is meeting the build schedule and building Quality product that meets customers’ expectations
• Directs collection and analysis of Quality KPIs from multiple sources to develop long-term Quality strategy and programs.
• Foster a safety-first mentality while improving efficiencies through the improvement of process flow, elimination of waste, and cost reduction through leadership, example, and training.
• With the support of VP Quality & Regulatory and in consultation with the VP of US Operations, develop and manage financial budgets for the US Quality department.
• Establish and ensure supplier quality and operation standards are acceptable and sustainable through the deployment of Kuros’s Supplier Quality program and inspection processes.
• Through the utilization of Kuros’ Supplier Quality Program establish and sustain a Supplier audit scheduled. Monitor supplier performance through monthly supplier performance meetings that address poor performance through PPM scores, Trending NCRs and SCARs.
• Prepare monthly reporting based on Global Quality KPIs and present results to the ELT.
• Prepare periodic reports identifying root cause(s) for product returns, identify corrective action(s), and make recommendations to improve overall longevity of product.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction, utilizing a DMAIC and DMADV structure.
• Provide leadership and the application of problem-solving initiatives through systemic tools such as lean manufacturing and six sigma.
• Maintain compliance with medical device quality system which includes leading and/or supporting corrective action preventative action initiatives (CAPAs), discrepant material disposition and Engineering Change Order (ECO) implementation.
• Ensure manufacturing systems that require calibration and maintenance are sustained through an appropriate calibration process and documented appropriately.

Qualifications & Skills:

• Education: Bachelor’s degree in Engineering, Biology, or Operational Management required. A Master’s degree in related fields or an MBA, preferred.
  • Lean Six Sigma Green Belt or Black Belt Certification preferred
  • ASQ Certified Quality Engineer or Certified Quality Manager cer