Quality Manager - (US-MA-Littleton - 01460)

Minimum Education: None
Jobcode: L:98518002
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This position requires a hands on manager who will lead the organization to implement, improve and monitor all company quality systems and to demonstrate compliance with ISO 13485:2003 and FDA QSR requirements.  The person will be responsible for managing diverse functional groups to assure compliance with the corporate Quality Management System and appropriate standards. Key Responsibilities: •    Maintain and continuously improve the ISO 9001 and ISO 13485 Quality Management System, functioning as the ISO Management representative. •    Maintain the Quality System Manual, coordinate all required standard operating procedures, and serve as the principal contact for ISO registrar. •    Develop, implement and coordinate training on released ISO procedures and forms. •    Reviews and approves product documentation, maintains document archives for DMR, DHR, and DHF. •    Manage the Quality function during the R&D process. Audit deliverables at Design Reviews and Phase Reviews. •    Manage internal audit quality program. •    Manage non-conformance system related to internal and external findings. •    Manage the Medical Device Reporting and Complaint File system (CAPAs). •    Maintains all necessary regulation and standards documents required for normal quality assurance, engineering, and operational activities. •    Provides regulatory guidance to management, and staff as required. •    Other Quality or related duties and tasks which may be required. Functional Expertise: •    10+ years in regulatory affairs, quality assurance or related engineering fields with a minimum 3 years in the medical device industry. •    In depth knowledge of current ISO 13485:2003 and FDA QSR regulations. Education Requirements: BS Degree in a related field ASQC Certificate in Quality or Reliability Engineering desired