Document Control Specialist - Quality

Description The Documents Control Specialist is a key member of the Quality department and will work in close collaboration with the Director of Quality, Quality Manager, Production, Marketing, Purchasing, Engineering, etc. This individual also serves as a document control database superuser for both company sites. General change processing in DCD, leading CCB, generation of quality reports and proactively recommending improvements, supporting internal auditing and backroom coordination during external audits, supporting document retention process. Responsibilities Provide change control support to all departments via change orders. Ensure adherence to quality and compliance requirements. Review proposed document/drawing changes and proofread against redlines to ensure accurate implementation. Document review and redline creation. Primary Administrator for Arena DCD. Review and analyze change requests and deliverables for compliance with documentation processes and standards before submitting for approval. Coordinate and facilitate the CCB. Coordinate change activities with other functional areas/sites. Transmit approved change orders externally as required and assure follow up and closure is documented. Provide training to various groups on ECR, ECO and related product data management processes. Assist Project Management with new product introductions as it relates to core data management responsibilities. Check all documents to ensure they fit the company format standards before making their submission for approval. Assist in periodic review initiatives and other related duties as required. Assist the Marketing Department with change control activities. Proficiency with generation of timely reports in DCD. Foster and promote a culture of continuous improvement. Other duties as assigned. Work Experience Requirements 3 to 5 years related experience and/or training; or equivalent combination of education and experience. Experience with product life cycle and data management systems (PLM). Ability to effectively present information to all audience levels. Intermediate or above Microsoft app proficiency. Experience with a medical device manufacturer in compliance with ISO 13485 or FDA preferred. Experience with Product Lifecycle Management (PLM). Experience with ERP systems. Excellent communication skills (both verbal and written). Highly detail oriented. Ability to effectively present information. Strong analytical and problem-solving skills. Self-motivated and proactive with strong customer service orientation. Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work. Experience with data organization and presentation. Excellent project management skills. Intermediate or above skill in the use of Microsoft Office Suite required. Project completion driven. #J-18808-Ljbffr Harmar Mobility LLC