Qureos Mentor

Kuros Biosciences

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 Overview:
 
 
 
 Contribute your technical manufacturing, leadership, and project management skills to a dynamic and fast-growing biotech company. This key technical role will have responsibilities in supporting Kuros' manufacturing by creating and validating manufacturing processes, managing continuous improvement initiatives, authoring all associated manufacturing documentation, and maintaining compliance with our quality system. This role will lead to the design, optimization, and scale-up of manufacturing processes and is critical to ensuring efficient, safe, and high-quality production. This is a full-time, on-site position.
 
 
 
 Key Responsibilities:
 
 
 
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 Join a core team of leaders to support the building of Kuros&rsquo; newest manufacturing facility in Alpharetta, Georgia.
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 Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ).
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 While utilizing Lean manufacturing tools, create, maintain and improve production process, refining BOMs, workflow processes, PFMEAs and detailed work instructions.
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 Create, design, develop, and optimize manufacturing processes to improve efficiency, yield, and product quality. Production of complex products with responsibilities including but not limited to:
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 Establish group and individual objectives, priorities, and metrics.
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 Ensure fulfillment of product development goals for Kuros projects.
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 Ensure production of products meets expected output.
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 Ensure quality requirements are fulfilled and maintained.
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 Maintain compliance with medical device quality system which includes leading and/or supporting corrective action preventative action initiatives (CAPAs), discrepant material disposition and implementation of Engineering Changes.
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 Develop and maintain detailed process documentation, including process flow diagrams (PFDs), SOPs, and batch records.
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 Ensure compliance with regulatory and safety standards (e.g., GMP, ISO, FDA, EH&amp;S).
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 Support capital projects from concepts through commissioning and validation.
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 Evaluate, select, and implement equipment and technology upgrades.
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 Lead process development for new and existing products and support scale-ups from R&amp;D to full production.
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 Preventive maintenance of equipment and utilities and troubleshooting if needed
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 Provide technical support for failure analysis and root cause investigation of product failures.
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 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.
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 Plan, budget and staff projects, tracking performance throughout.
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 Manage and allocate team resources over multiple projects.
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 Provide and solicit resources to and from other teams as necessary.
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 Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.
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 Improve product quality, yield, and reduce costs.
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 Analyze instrument-manufacturing lines from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
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 Provide production line support for day-to-day engineering issues on core equipment.
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 Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
 
 
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 Qualifications:
 
 
 
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 Education:
 
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 Bachelor&rsquo;s degree in Engineering, Biology, or related field required. A Master&rsquo;s degree in related fields or an MBA, preferred.
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 Lean Six Sigma Green Belt or Black Belt Certification preferred
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 Experience:
 
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 3+ years in Manufacturing, Process or Quality Engineering in an ISO13485 regulated industry
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 Experience with regulatory environments such as GMP, FDA, or ISO standards
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 Skills:
 
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 Strong analytical and problem-solving skills
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 Excellent communication and interpersonal abilities
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 Proven experience in performing IQ, OQ,PQ's
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 Proficiency in process control, lean methodologies and Six Sigma tools
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 Experience in the identification of the 8 wastes, line balancing and performing theory of constraints
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 Experience in developing and sustaining morning markets and value stream structure organization
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 Experience in performing Gage R&amp;R's, attribute agreement analyses, and MSA's
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 Experience in performing Cpk Analyses for either in process inspections or incoming inspections
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 Proficiency in data analysis tools and software such as minitab, powerBI, Tableau
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 Proficiency in ERP and Master data, preferably in Microsoft Dynamics 365
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 Experience in developing and sustaining a Supplier Quality program that monitor supplier program using KPIs such as PPM, SCARs, and OTD
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 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
 
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 Travel Requirement:
 
 
 
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 Ability to travel domestic and international
 
 
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 Pay Range: $87,000 USD - $90,000 USD
 
 
 
 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.
 
 
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 Mobility &amp; Posture
 
 : May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
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 Lifting/Carrying
 
 : May require lifting and carrying items 50 pounds or more, depending on the role.
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 Manual Dexterity
 
 : Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.
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 Driving
 
 : Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver&rsquo;s license.
 
 
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 Specific requirements may vary by role. Contact an HR representative for details related to the position.
 
 
 
 
 Our credentials
 
 
 
 Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016 (under symbol KURN). With additional operations in the Netherlands and the USA, we continue to grow our global team.
 
 
 To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to advance bone healing.
 
 
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 Listing on the SIX Swiss Exchange under the symbol KURN since 2016
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 A commercial &amp; research footprint that spans &gt;20 markets
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 4 teams of internationally renowned clinical and scientific expert advisers
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 &gt;25
 
 orthobiologics-related patents
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 &gt;400 patients evaluated
 
 in Level I, randomized controlled clinical trials
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 &gt;20
 
 well-controlled Level I-IV clinical trials initiated, including 6 that are complete1
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 Published Level I evidence published in Spine
 
 
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 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.
 
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Process Development Engineer

Join Kuros Biosciences and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Kuros Biosciences

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Process Development Engineer