What are the responsibilities and job description for the Medical Device Document Control Coordinator position at Avantik?
Our mission is to exceed our customers' expectations as their most reliable, innovative, and trusted lab resource. We achieve this by partnering with customers to solve their most pressing day-to-day challenges and always holding ourselves to a higher standard of product quality, exceptional service, and unmatched support.
Summary/objective
The Medical Device Document Control Coordinator will be responsible for ensuring that documents of all types (e.g. procedures, forms, labels, training materials, standards, etc.) are reviewed and approved prior to issue and in conjunction with needed revision.
The incumbent will have the ability to work within an electronic document control system and work cooperatively with other departments to ensure the needs of those departments for access to approved documents are met.
The Document Control Coordinator will be involved in helping to support the Quality department during customer audits and inspections by regulators, such as FDA, by making sure documents are available upon request, and may be called upon to take notes during such activities. They will also be called upon to provide training for new associates on Good Documentation Practices (GDP).
Essential functions
- Revisions and approvals of documents
- Placing into the Electronic Document Control System
- Scanning and maintaining critical documents of external origin (e.g. prints, formulas, Safety Data Sheets)
- Running reports
- Provide training to new hires on Good Documentation Practices (GDP)
- Working within the organization to problem solve and support corrective actions and improvement activities
Competencies
- Good organizational skills
- Good presentation skills
- Computer literacy
- Ability to work independently and as part of a team
Other duties
As assigned by management Avantik is an integrated medical products and services company delivering superior quality instruments, reagents, consumables, and service to the anatomic pathology market consisting of hospital, reference, and physician office laboratories in the US. The company is headquartered in Montville Township, NJ.
Avantik’s experienced team and consultative partner approach integrates consumables, service, equipment, and education so that labs focus on what matters most - having everything under control in their laboratory to deliver fast and accurate diagnoses. Avantik offers a full line of consumables and reagents for the histology lab sourced and private label Avantik branded and by distribution of other brands. Avantik has serviced all brands of OEM histology lab equipment for over 40 years and offers best-in-class responsiveness and an industry leading 97% first time fix-rate.
Avantik offers a team orientated, customer service focused environment with competitive compensation, bonus programs, medical (company covers 85% of the cost), dental and vision insurance, 401K (with a match) and more.
Learn more at www.avantik-us.com
Avantik is an Equal Opportunity Employer.
Salary : $35,700 - $45,100