Manager, Regulatory Affairs Trauma
Synthes North America - West Chester, PA
Manage Regulatory activities for the division.Represent global regulatory affairs position and implications of regulatory science on product development teams.Develop global, regional and multi-country regulatory strategy for individual new or modified products and update strateg...
Complaint Investigation Engineer
Synthes North America - West Chester, PA
Responsible for the coordination of all aspects of product complaint investigation in accordance to CFR 21 Part 820 and 803. Duties & Other Responsibilities: * Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethic...
Manager, Technical Training Curriculum
Synthes North America - Paoli, PA
This position will focus on the clinical and technical instructional design of all training programs for the Spine Training department to ensure accuracy and continuity in program and staff development. Duties & Other Responsibilities: * Develop and enhance all training materials...
Synthes North America - Palm Beach Gardens, FL
This individual will also have coordination and/or facilitation responsibilities for special projects associated with internal compliance projects and with regulatory body activities. Another prime responsibility may be to serve as primary or alternate liaison during external aud...
Synthes North America - Palm Beach Gardens, FL
Plan, organize and procure commodities such as sub-contract components, finished product, packaging, tools, capital equipment, services and supplies. Ensures quality and delivery requirements are in compliance to the company requirements. Through coordination and negotiation with...
Manufacturing Engineer - Heading Department
Synthes North America - Monument, CO
Supports an assigned manufacturing operation in the areas of processes, new product implementation, CNC programming, machinery and tool/gage acquisition, layout, scrap tool management, continuous improvement methodologies and other operational issues. Works independently addressi...
Synthes North America - West Chester, PA
Supports assigned manufacturing operations, (i.e., machine shop, sheet metal shop and final assembly) in the areas of process development, tool design, machinery & equipment acquisition, layout and operations, and other duties associated with engineering support of production. Al...
Synthes North America - West Chester, PA
This position is responsible for reviewing quality issues and assigning responsibility for their correction; reviewing and approving proposed corrective and preventive actions (CAPA); and assessing the effectiveness of completed CAPA. Duties & Other Responsibilities: * Ensure the...
Synthes North America - West Chester, PA
Develop, implement and maintain Quality System requirements on assigned areas of Manufacturing, Supplier management, Process Validation and New Products Introduction. Areas of responsibility may include: Non-conforming product, CAPA, Calibration Systems, Supplier Auditing, Steril...
Corporate Compliance Specialist
Synthes North America - West Chester, PA
Supports division compliance program responsibilities, including, but not limited, to, Concur automated expense reporting and aggregate spend reporting, grant and consulting processes and reporting, annual budget tracking and compliance review program processes and reporting. Dut...
Synthes North America - West Chester, PA
Complaint Handling Unit (CHU) member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. Additionally these activities may include Non-Conformance Investigations, Field Actions, Documentation Management and ...