Sr. Quality Manager – Medical Device Company – Central MA

Responsibilities: Plan, develop and monitor the Quality Management System to ensure that all quality objectives are met as well as the Operational, Process Improvement, Product Development and Transfer processes are implemented in an efficient and effective manner. You will be responsible for providing support and communication with operation groups and with customers to resolve design […]

Director / Assoc Dir of Regulatory Affairs – Central MA

Summary of Responsibilities: 1.Interpret regulatory requirements and maintain current and in-depth knowledge of FDA, European and Worldwide Regulatory Authority programs, policies and guidelines. Work effectively across different cultures and markets. 2.Analyze regulatory requirements and assess regulatory impact and risks. Advise on regulatory options and recommend viable options to management. 3.Determine product regulatory path and compile […]

Sr. Program Manager – Central MA

The Program Manager will be responsible for the project management in the development of new or enhanced products. •Work with departmental management and staff to develop project documentation, such as User Needs, Design Input Requirements, Design Outputs and Risk Management documentation for new products and product enhancements. Work with other departments within company to gather […]

Principal / Sr. Supplier Quality Engineer – Central MA

Supplier QA Engineer will focus on strengthening supply chain management process by leading and supporting: Supplier Selection process, Supplier Evaluation and Acceptance, Finalization of Controls, Supplier Validation activities (IQ, OQ, PQ), Supplier Audits, develop, manage, and maintain Supplier Quality Management Metrics to enable proactive, metric-driven management of the Quality Supplier relationships and purchasing controls processes […]