Quality Document Control & Compliance Manager (Medical…

Job Description
KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:
Manage Document Control staff to ensure all assigned activities are completed and in conformance to cGMP, ISO 13485, and customer requirements
Assist the Quality Manager in coordinating and executing objectives throughout the company in cross-functional cooperation to maximize product quality and operating systems
Participate in central compliance and regulatory meetings
Develop training for shop floor employees to align job roles
Identify and coordinate resolution of system(s) inefficiencies that contribute to increased quality costs
Track and trend customer notifications to monitor timely completion and to recognize repeated issues
Manage CAPAs to ensure all steps are followed to prevent aging
Incorporate CAPA approach for responses to internal and external audit observation
Support customer Quality Agreement review from compliance and regulatory standpoint
Coordinate and support regulatory and customer audits
Assesses results and effectiveness of Customer Complaint investigations and Corrective Actions for application, validity, and conformance to regulatory, ISO and customer requirements
Responsible for tracking and trending quality systems KPIs to identify gaps and propose corrective actions
Execute specific responsibilities as defined within the company quality management system
Supports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives
Represent the Quality Department in support of customer, ISO, and third-party audits
Carry out managerial responsibilities, in accordance with the organization’s policies and applicable laws. Participates in interviewing, hiring, and training employees
Other duties as assigned
POSITION REQUIREMENTS:
Bachelor’s Degree in Sciences or Engineering discipline preferred
Minimum of 5 years’ experience within the quality profession or a Medical Device Industry
Minimum 3-5 years' experience in leadership or supervisory role
Experience working in a manufacturing environment preferred
Minimum 3-5 years 
PREFERRED KNOWLEDGE/SKILLS:
Excellent communication and organizational skills
Ability to use common software productivity tools, such as Word, Excel and PowerPoint