- Olympus Corporation of the Americas (Westborough, MA)
- …of the OSTA HF team and as an Human Factors expert providing project support, mentoring and guidance in Human Factors and Usability Engineering processes, managing ... for the region. + Strategically plan OSTA Projects at times with project HF team member, determining required activities and level of effort, resourcing.… more
- Technical Safety Services (Boston, MA)
- …in the United States. How will you make an impact? The Validation Manager leads the planning, execution, and documentation of equipment, systems, and process ... is performed accurately, consistently, and in alignment with regulatory guidelines ( FDA , cGMP, ISO) and customer-specific protocols. This role partners closely with… more
- Fujifilm (Boston, MA)
- …the assistance of technical support, as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Beth Israel Lahey Health (Burlington, MA)
- …aspects of clinical trials research adhering to Research SOPs, GCP compliance and FDA regulations. 2) Functions as a mentor, resource and educator for clinical ... data. + Identifies data management issues with PI / sponsor. 7) Organizes project team meetings and prepares the agenda under direction of the principal… more
- North Coast Seafoods (New Bedford, MA)
- …department's requirements are met. This position will report to a Production Manager . DUTIES AND RESPONSIBILITIES + Assist with managing the processing of products ... hours + Drive an environment of teamwork and open communication + Accountable for project completion and achievement of such goals + Help manage an environment that… more
- Integra LifeSciences (Mansfield, MA)
- … Manager . Works independently under general supervision, reviewed at project milestone and/or completion by senior management. **Essential Duties and ... plant internal audit system as the site Internal Audit Manager . + Supports external Quality System audits in key...improvement activities. + Writes reports and presents progress at project meetings. + Achieves goals within established budgets. +… more
- Integra LifeSciences (Mansfield, MA)
- … Manager . Works independently under general supervision, reviewed at project milestone and/or completion by senior management. **Essential Duties and ... other CAPA owners + Provides root cause analysis assistance + Provides project management support for CAPA action items, including leading meetings and… more
- Stantec (Burlington, MA)
- …and analysis, to support buildings engineering projects with a primary focus in FDA regulated facilities - Perform basic calculations to analyze, model and design ... engineering disciplines and professionals in the coordination of the project under the direction of a senior engineer. -...work from home is negotiable per agreement with hiring manager . Intermittent travel for client site visits may be… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Affairs' efforts in creating submission materials for various regulatory domains including FDA , PMDA, and EU-MDR. **Job Duties** + Advise SW development teams on ... rapid product delivery while maintaining compliance and quality. + Provide project management oversight for QMS integration, Quality plans, process updates, and… more
- System One (Boston, MA)
- …interpret information and protocol requirements, and initiate appropriate actions Assist Sr. Project Manager with documentation and follow up paperwork for the ... priorities Comfortable with hospital in-patient and out-patient environments Responsibilities: Assist Sr. Project Manager and team members with all phases of… more
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