Looking for a self-motivated, highly organized team member who can jump into our Quality Management System (QMS) development and implementation and have immediate, positive impact.
Regulatory requirements for quality system records, risk management, design control, change control, CAPA, design and process validations, internal audits, and supplier qualification are all familiar terrain for you. You will work closely with internal and external collaborators to oversee our Product Lifecycle Management (PLM) software and will own maintaining our electronic documents of record. You will oversee supplier audits and maintenance of our supplier qualification program. Balancing prioritization of multiple, simultaneous activities to support our growing company comes naturally to you. You will work closely with scientists in assay development and mechanical, electrical and software engineers to support product development. You will be a critical driver in bringing our products through regulatory review and to market.
Lead development and implementation of Quality policies and practices.
Manage timelines and resources (internal and external) to meet program goals
Orchestrate and document design reviews, training plans, internal/external audits, etc.
Support Quality activities related to product development, regulatory filings, and commercial manufacturing
Provide reports on QMS activities to Alveo’s management team
Develop team engagement and build company-wide Quality savvy
Bachelor’s degree or equivalent,
Relevant professional experience in a regulated industry
5 years of roles of increasing responsibility in Quality working on Medical Device products
3 years leadership experience
Experienced in QSR and using PLM softwareDiversity and flexibility to support
goals in collaboration with different disciplines
Participation in regulatory submissions
Excellent verbal communication skills to work cross-functionally across multiple departments
Clear technical writing skills (English) to develop procedures, specifications, and training
Quality leadership role working on IVD products from research through commercialization at a start-up