We offer an excellent opportunity for a Quality Systems Assistant to support in the maintenance of the Document Control system at IVMI. The most critical functions include: updating, routing, monitoring, formatting and implementation of documents within the various document control systems at IVMI. Document control and ensuring documents and the document control system function per internal specifications are the major tasks associated with this position.
Ivoclar Vivadent Manufacturing, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet.
- Support the Document Control Systems at IVMI. Monitor and circulate all documents in the approval and training process. Ensure documents are updated, issued and reviewed per internal specifications.
- Maintain document tracking databases such as validation document spreadsheets, calibration and maintenance schedules. Monitor for completion within timeframes as directed.
- Maintain Quality System documents, including departmental procedures and specifications. Create new specifications and update existing specifications as assigned. Process documents through implementation, filing and archiving processes including physical and electronic record storage locations.
- Perform administrative functions associated with QA department, such as purchasing lab supplies, filing quality records and SDS’s, generating process maps and flowcharts.
- Perform acceptance reviews on incoming products per specifications, including raw materials, labels, and packaging as assigned
- Enter data into LabsQ and SAP Inventory Management information, such as vendor file maintenance, testing criteria and release status.
- Support the label and labeling approval process. Create specifications as assigned. Monitor the intercompany label approval process as assigned.
- Assist in internal audits and provide support for regulatory inspections.
- Perform other related duties and assignments as assigned.
- Associates degree or 2 years related work experience, preferably in Quality Assurance in the Medical Device
- Manufacturing Industry or ISO 13485 environment. Some college level courses desired.
- Excellent organizational skills, detail oriented and ability to multi-task.
- Excellent communications skills, both written and oral.
- Exhibits excellent written and oral English language skills.
- Interpersonal skills – ability to work with people from all levels of the company.
- Ability to work independently with little or no supervision
- Ability to effectively manage time to meet assigned deadlines.
- Advanced computer literacy including formatting skills in the following areas: Microsoft Word, Excel, Visio, and Outlook.
- SAP, QUMAS, and/or laboratory information systems experience helpful.
Ability to sit or stand for up to 8 hours per day, view computer monitor and move about effectively to fulfill the essential
functions of the job. Ability to bend and kneel to file away documents. Manual dexterity needed to operate keyboards.
Ivoclar Vivadent is a global leader in innovative materials and processes for quality, esthetic dentistry. With North American headquarters in Amherst, New York, and a Canadian office in Mississauga, Ontario, Canada, the company serves dentists and dental laboratory professionals across the continent.
Location/Region: Somerset, NJ (US)