Document Control Specialist - Quality at Harmar Mobility LLC

Sarasota, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Aug, 26

Salary

0.0

Posted On

22 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Control, Change Control, PLM, ISO 13485, FDA Compliance, Arena DCD, ERP Systems, Microsoft Office Suite, Project Management, Internal Auditing, Data Management, Quality Reporting, Technical Proofreading, CCB Coordination, Analytical Skills, Communication Skills

Industry

Medical Equipment Manufacturing

Description

Description Want a fulfilling job while working for a Great Place to Work certified company? Looking for opportunities to grow in your position and enhance your craft? Do you enjoy working with a team, where your opinions and ideas are strongly valued? Lift your life by joining Harmar Mobility where our purpose is to lift lives within our team, among our network of dealers, and in our communities across the nation. We manufacture mobility device lifts for vehicles and accessibility products to help those with mobility difficulties enjoy their independence and continue to make meaningful memories, whether they’re at home or on the road. 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. Requirements 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.

Responsibilities

The Document Control Specialist manages the document control database and coordinates change control processes across multiple departments. They are responsible for leading the Change Control Board (CCB), generating quality reports, and supporting internal and external audits.