Vacancy caducado!
100% Remote
We have an excellent job opportunity available as a Quality Systems Manager!This role is expected to last 6 months.We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Responsibilities of the Quality Systems Manager:- Audit and perform gap assessments on the Quality Management Systems
- Develop Quality plans for integration of new entities into the Align QMS
- Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project
- Mange and implement new quality initiatives within the site including the implementation of Corporate Policies and Procedures
- Guide functional & cross-functional teams in the definition of core quality system processes
- Assist in maintenance of an ISO 13485:2016, EU MDD/MDR, FDA 21 CFR Part 820, compliant Site Quality Management System
- Conduct Quality Systems audits and assist in training/guidance to other auditors
- Assist with preparation and hosting of external Quality System inspections
- Managing internal audit, training, document control and records personnel
- ISO 13485 and MDSAP auditor experience, Lead Auditor certification or training preferred
- Knowledge of US and International laws and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR/IVDR, Canadian MDR, Japan PMDA as well as ANVISA requirements
- Software as A Medical Device (SaMD) experience preferred
- Creative problem-solving skills with exceptional verbal and written communication skills, and the ability to mentor others in Quality Management Systems
- Minimum 6 years of experience in medical device environment
Vacancy caducado!