Quality Systems Program Mgr at Three Point Solutions Inc
Mounds View, MN
About the Job
Job Title: Quality Systems Program Manager
Client: Medical Device Manufacturing Company
Duration: 1 year and 7 months
Location: Mounds View, MN 55112
Shift: 1st Shift
Technical Skills
Must Have:
- 5+ years of project management experience
- Knowledge of 21CFR803, 21CFR820
- Knowledge of Medical Device Risk Management Methodology
- Understanding of Medical Device Quality Coding for Complaint Handling
Nice To Have:
- Experience implementing software systems for Quality Applications
Job Description
Responsibilities:
- Lead interdependent workstreams for Risk Management, Medical Device Coding for Complaint Handling, and Post-Market Surveillance.
- Collaborate with "NextGen Complaint Handling Software" Project teams and other workstreams.
- Define and refine coding structure for Complaint Handling process and Software, aligning with Risk Management for efficiency, automation, and compliance.
- Implement a compliant, efficient Risk Management approach in NextGen Complaint Handling software and process.
- Oversee development and maintenance of quality programs and systems, ensuring compliance with policies and performance standards.
- Provide guidance on interpreting policies, regulations, and internal standards.
- Align with program objectives, facilitate global standards, and share best practices.
- Accountable for program process, performance, and customer satisfaction.
Organizational Impact:
- Establish program objectives, timelines, milestones, and budgets.
- Recommend policies affecting program management.
- May have budget accountability.
- Consult with higher management for decisions.
Innovation and Complexity:
- Solve complex problems impacting multiple workstreams or departments.
- Modify program management processes for improvement.
Communication and Influence:
- Lead meetings and briefings with internal/external customers and vendors.
- Solve issues through influence and persuasion.
- Directly involved in daily tasks for program execution.
Knowledge and Experience:
- Advanced knowledge in Medical Device Quality/Regulatory.
- Requires a Bachelor's degree (or equivalent) and 5 years of relevant experience, or an advanced degree with 3 years of relevant experience.
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