Quality Systems Program Manager
Location: Mounds View, MN
Contract Duration: 19 months
Pay Rate: $65 - $77.50 per hour (competitive, based on experience)
Position Overview:
We are seeking a seasoned professional to lead a critical workstream focused on Risk Management and Medical Device Coding for Complaint Handling and Post-Market Surveillance. This role will involve collaboration with project teams implementing the "NextGen Complaint Handling Software" and other related workstreams.
Key Responsibilities:
- Workstream Leadership: Oversee the Risk Management and Medical Device Coding processes related to Complaint Handling and Post-Market Surveillance.
- Collaboration: Work closely with the "NextGen Complaint Handling Software" project teams to ensure seamless implementation and integration.
- Process Optimization: Define and refine the coding structure for future Complaint Handling processes and software to enhance efficiency, automation, and compliance.
- Risk Management: Develop and implement a compliant, consistent, and efficient approach for Risk Management in alignment with the NextGen Complaint Handling software and process.
Required Qualifications:
- Experience: Minimum of 5 years in project management, with a strong background in Medical Device Risk Management and Quality Coding for Complaint Handling.
- Regulatory Knowledge: In-depth understanding of 21 CFR 803 and 21 CFR 820.
- Medical Device Expertise: Proven experience with Medical Device Risk Management methodologies.
Preferred Qualifications:
- Software Implementation: Experience with implementing software systems for Quality Applications.
Key Competencies:
- Organizational Impact: Contribute to the establishment of program objectives, timelines, milestones, and budgets. Recommend policies and procedures impacting program management. May have budget accountability.
- Innovation and Complexity: Address complex problems that impact multiple workstreams or departments, requiring detailed analysis and modifications to improve processes.
- Communication and Influence: Lead meetings, communicate effectively with internal and external stakeholders, and influence without direct authority to ensure successful program execution.
Education and Experience Requirements:
- Education: Bachelor’s degree (or equivalent, as defined by U.S. regulations) or advanced degree.
- Experience: Minimum of 5 years of relevant experience for a bachelor’s degree or 3 years with an advanced degree.
