Spotlight Call with HM: 11/7 @ 10am CST Dial in by phone +***, Phone conference ID: 963 950 653# Target BR: ***/hr
Must Have: Competency in Microsoft Productivity Suite Fluent Communication with internal contacts with immediate group Nice to Have: Knowledge of 21 CFR Part 820 - Quality System Regulation Knowledge of Atlassian products; JIRA specifically Knowledge of or experience with Medical Device Quality System, ISO 13485, and Risk Management, ISO 14971, requirements
The position is pretty much entry level. The scope of the role will be supporting the Robotic Surgical Technologies post-market Quality organization with management of: Scoping and Bounding for post-market inquiries Reconciliation and disposition of product returns and product hold orders Completing queries for sales, distribution and post-market events.
Education: Bachelor degree Yrs Experience: 0 3 yrs Work Week: 40 hrs Work Location: On-site in North Haven, CT; may be hybrid ie 4 days in the office, 1 remote
Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Assoc Quality Systems Spec - Exempt • North Haven, CT, United States
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