Manager, Quality Assurance EMEA

About this opportunity This position is mainly responsible for accomplishing results through management of professional individual contributors and/or skilled, support individual contributors in the following areas: support for operational departments in the field of quality related processes like: CAPA, audit, complaint handling, supplier evaluation, document control activities, QMS training, etc. This position reports directly to Director, QA Operations EMEA. In this role, you will… Ensure that the EMEA QMS is in compliance with the requirements of ISO 13485, FDA’s Quality System Regulations (QSR) and Regulations (EU) 2017/745. Maintain the EMEA Quality Management System (QMS) and keep it simple, pragmatic and easy to understand. Identify, analyze and lead the implementation of continuous opportunities for improvement (process and/or quality) focused on exceeding customer needs. Lead internal and cross-functional teams in process quality improvement efforts. Ensure that appropriate quality documentation is in place, implemented and effective and improve quality documentation based on business needs. Coordinate complaint handling and root cause investigation for local departments at the facility. Responsible for working with appropriate staff (Supervisors, Technicians, Clinical, training, etc.) to investigate root causes, put corrective action in place, and monitor results (coordinates CAPA activities locally). Take leadership in risk analysis regarding process, product or design. Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems. Provides direction and management guidance to employees according to established policies and procedures. Be involved in any global or outside agency inspections relating to Quality Management System, if required. Manage the audits (internal, global and supplier) in order to verify the Quality Management System compliance. Prepare, in collaboration with the EMEA QA-RA team and other relevant stakeholders, the EMEA level management review of the EMEA QMS meetings. Responsible for ensuring that appropriate quality controls are in place in the process. Participate in proactive team efforts to achieve departmental and company goals. Serves as general subject matter expert for quality processes & project teams. Supports, guides, and coaches the process owners and stakeholders. Ensures the effective fulfillment of quality objectives and deadlines assigned. Ensure site document control procedures comply with local or country specific regulations as well as internal policies and procedures, translations of documents must be controlled. Be responsible for maintaining and ensuring the site change control process in Align EDMS, including the review of change control documents and deliverables. Escalate nonconformities in the QMS to upper management and provide solutions, where appropriate. Ensure review and assistance in resolution of documentation issues (e.g. change control, document archiving, procedures, etc.) and translations. Ensure review all electronic documents submitted to change control for correct formatting, spelling and clarity of text before obtaining approval. Ensure proper co-administration of Aligns EDMS documentation system. Give QMS and medical device regulations related training to the organization as needed. Work with Production, Customer Success, Marketing, Engineering, Clinical, Training, and all other functions to increase Quality Awareness. Comply with all safety policies, practices and procedures. Report all unsafe activities to superior and/or Human Resources. Perform other duties as assigned. In this role, you'll need... Bachelor’s or Master's Degree, Post graduate studies related to Quality Management area or related experiences would be a plus. 3+ years of experience in supervising/leading role or equivalent combination of education and extensive proven experience in QMS development and implementation within the Medical Device Industry. Extensive practical Internal Auditor experience in performing internal quality audits A broad understanding of the Quality System regulations for medical devices (21 CFR, ISO 13485, MDR 2017/745, GMP, etc.). Quality assurance experienced in the whole value stream (Supplier-Process-Customer) Native speaker of local language and English language proficiency (written and spoken). Excellent advanced Computer skills in Microsoft Office required. Ability to provide direct supervision to individuals. Demonstrated leadership; ability to listen and speak effectively, ability to solve problems and communicate issues; ability to work on multiple projects. Must have exceptional level of commitment and a positive can-do attitude. Ability to do research and come up with creative, compliant solutions for Quality Management System challenges and attention to detail. Must have good interpersonal skills and be able to work independently as well as in close collaboration with others. Have exceptional problem-solving and decision-making skills.