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 certification preferred.
• Experience: 5+ years in Quality Engineering or management in an ISO13485 regulated industry
  • Experience with risk management, design controls, and validation practices
  • Demonstrated success managing quality systems and leading audits
  • Strong knowledge of US regulatory requirements, including FDA and ISO 13485.
• Skills:
  • Strong analytical and problem-solving skills
  • Excellent communication and interpersonal abilities
  • Proven leadership and team management expertise
  • Proficiency in lean methodologies and Six Sigma tools
  • Proficiency in data analysis tools and software such as minitab, PowerBI, Tableau
  • Experience in developing and sustaining a Supplier Quality program that monitor supplier program using KPIs such as PPM, SCARs, and OTD
  • Experience in developing and continuously improving upon Quality KPI's such as First Pass Yield, NCR's, Inventory Accuracy, and Monitoring budget to fiscal year plan, CAPA closure rate and cycle time, Audit success rate

Travel Requirement:

• Ability to travel internationally

Physical Requirements and Work Conditions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
• Lifting/Carrying: May require lifting and carrying items up to 50 pounds, depending on the role.
• Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.
• Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver’s license.

Specific requirements may vary by role. Contact an HR representative for details related to the position.

About Us

Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies.

Our Credentials

With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company’s first commercial product, MagnetOs^TM, is a unique advanced bone graft that has already been used across four continents. For more information on the company, its products and pipeline, visit kurosbio.com.

• Listing on the SIX Swiss Exchange under the symbol KURN
• A commercial & research footprint that spans >20 markets
• 4 teams of internationally renowned clinical and scientific expert advisers
• >25 orthobiologics-related patents
• >400 patients evaluated in Level I, randomized controlled clinical trials
• >20 well-controlled Level I-III clinical trials initiated, including 6 that are complete
• Level I evidence published in Spine

Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.