Role: Project Manager I
Location: Westbrook, ME - 04092
Duration: 07 Months
RESPONSIBILITIES:
• Lead key initiatives and support the IVDR changes that are needed incollaboration with Product Transfer team, Regulatory, Quality, and otherdepartments.
• Manages regular cadence of interaction between internal team and TPMs.
• Regularly collaborates with international employees and departments,effectively managing projects across diverse teams to ensure successfuloutcomes.
• Support business process improvement activities to continuously improve project deliverables.
• Ensures meetings are run with proper direction and helps set goals,milestones, and appropriate ownership of tasks with clear due dates.
• Proactively identifies and resolves issues, including recognizing potentialrisks and developing effective action plans to mitigate project delays.
• Efficiently manages multiple projects simultaneously, ensuring that alltasks are completed on time and within established deadlines.
• Ensures adherence to all relevant design and compliance requirements,maintaining high standards and regulatory compliance throughout the project lifecycle.
• Utilizes Process Failure Mode and Effects Analysis (PFMEA) to driveproduct changes, ensuring improvements are systematically identifiedand implemented to enhance product quality and reliability.
BASIC QUALIFICATIONS | EDUCATION:
• Associates Degree in Project Management or an equivilent combinationof education and experience.
• 3+ years’ experience in Project Management.
• Experience in Microsoft Suites software. (Microsoft Excel, PowerPoint,Power BI, Microsoft Project etc.)
PREFERRED QUALIFICATIONS:
• 1+ years’ experience working in a regulated enviroment.
• 1+ years’ experience in healthcare device manufacturing or durable medical equipment manufacturing
• Training or certification in Lean Six Sigma manufacturing principles.
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