The Senior Quality Manager leads the development and maintenance of company’s quality systems including CAPA’s, deviations, and document/change control. Serves as quality team member for product development teams. Responsible for the design and implementation of policies and procedures to ensure that quality standards are met for the organization and the full lifecycle of the devices. Responsible for compliance functions including the Quality Assurance laboratory and respective incoming, in process, and lot qualification testing.
· Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.
· Provide expertise and guidance in interpreting and applying governmental regulations, agency guidelines and internal policies to assure compliance as it pertains to Quality Operations practices.
· Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions
· Coordinate the reporting, analysis, and resolution of material non-conformance incidences.
· Participate in Design Review meetings.
· Develop quality assurance specifications, test methods, sampling plans and related written procedures.
· Coordinate the identification, assignment, monitoring, and completion of product improvement projects.
· Qualify and implement Document Changes Notices involving product or process changes.
· Collaborate with Regulatory Affairs Department in preparation of regulatory submissions.
· Oversee internal audits and external audits from various regulatory agencies Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
· Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, and Research and Development functions.
· Provide support in the rapid resolution of product complaints and/or safety issues.
· Work with the Manufacturing, Clinical Affairs, Sales and Marketing, and Research and
Development functions to coordinate pilot production of new products.
· Actively participate on new product development projects ensuring that product design inputs are clear, concise, testable and appropriate, and that design outputs confirm compliance to the design inputs
· Provide support to product development teams by developing test plans.
· Other miscellaneous responsibilities as required
Team of quality engineers, technicians, laboratory associates.
Medical Device experience, preferably Class II or III, in an ISO-registered company, preferably ISO 13485, GMP.
Minimum five years related quality experience in the medical device industry
Deep understanding of ISO 13485 and its implementation and maintenance requirements.
Knowledge and experience with Six Sigma and Lean Manufacturing techniques and tools a plus.
Understanding of regulatory requirements associated with health and medical technologies.
Very good verbal and written communication skills.
Computer skills: Working knowledge of MS Word, Excel, Access, and PowerPoint.
Ability to work without direct supervision with a sense of urgency to meet projects goals and customer expectations.
Must be energetic with a good attitude and be versatile in the areas of Quality Assurance, Engineering, R&D, and Manufacturing preferably in a small company.
Ability to take direction and pursue goals with minimal supervision.
Mitralign, Inc. is the valve repair company with the only direct transcatheter annuloplasty system designed to treat both functional tricuspid regurgitation and mitral regurgitation. We are a venture-backed, medical innovation company located near Boston, Massachusetts, USA.
We’ve developed an innovative therapy for the reduction of functional mitral regurgitation (FMR), a life-threatening cardia...c condition affecting four million people in the U.S. alone1. The Mitralign Percutaneous Annuloplasty System, MPAS, is intended for the treatment of symptomatic functional mitral regurgitation (MR ? 3+) for annular reduction through tissue plication. In addition, we have developed an approach to treating tricuspid valve regurgitation with a delivery system designed for transcatheter tricuspid valve repair. Our unique system provides a new solution for interventional cardiologists and their patients.