.The Quality Manager will lead others, and will be responsible for maintaining compliance to the FDA QSR and ISO 13485, primarily in the areas of Production Quality Assurance and Control, Incoming Inspection, Document Control, Supplier Controls/SCARs, MRB/NCMR's, Internal Audits and External Audits. The QA Manager will be a strong technical resource who will quickly, effectively and permanently resolve quality problems both internally at Vapotherm and externally at suppliers as needed.Primary Responsibilities (Bulleted form):- Plan, lead and manages projects, budgets and personnel for Quality Assurance- Evaluates and monitors manufacturing issues, product concerns, to determine corrective and preventive actions- Has a strong understanding of Risk Management and applies a balanced approach **Lead, coach, mentor direct reports**- Leads and Manages the areas of o Production Quality Assurance and Controls o Manufacturing support including MRB and NCMR's o Incoming and Finished Goods Inspection o Quality Engineering support o Internal Audits o External Audits (i.E. Notified Body audits or quarterly audits to support EMC certs o Documentation Control o Supplier Quality, Supplier Audits, SCAR's approvals o Compliant investigation and correction- Identifies opportunities to improve processes, e.G., lean techniques- Promotes a culture of continuous improvement, reinforces the elimination of process waste, and supports business improvement and profitability- Some travel, including International travel may be required for Supplier Audits Position**Requirements**:- Education, Knowledge, Years of Experience, etc. (Bulleted form):- Bachelor's degree in Engineering, Science or Quality and 5-15 Years leadership experience in quality field, mainly with medical device (biotech and pharma experience also acceptable)- Expertise in ISO 13485, 21 CFR 820, ISO14971 and other related regulations- Experience with CAPA/SCAR- Supplier Quality Experience **Strong attention to detail**- Highly organized **Fluent in English and Spanish**- Good communication skills, both written and oral- Present a professional demeanor and demonstrate an ability to work effectively with a diverse group of individuals- Must be energetic, work quickly and efficiently with detail and accuracy- Must be able to effectively manage multiple priorities in a fast paced and dynamic environment- Must have experience with and demonstrable competencies in Lean Manufacturing (e.G. Toyota Production System)