Document Control Specialist - Quality
Harmar Mobility, LLC
Job Type
Full-time
- 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
- 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.
Vacancy posted 23 hours ago
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