Quality Systems Program Mgr
8200 Coral Sea Street Northeast New Brighton, MN 55112 US
Job Description
Responsibilities may include the following and other duties may be assigned:
- Responsible for leading an interdepending workstream for Risk Management and Medical Device Coding for Complaint Handling and Post-Market Surveillance.
- Provide workstream ownership and collaboration with "NextGen Complaint Handling Software" Project implementation teams and other workstreams.
- Help to define and refine coding structure for future Complaint Handling process and Software in alignment with Risk Mananagement to drive effeciencies/automation and compliance.
- Help define and implement a compliant, consistent and efficient approach for Risk Management implementation in NextGen Complaint Handling software and process.
Must Have
- 5+ years of previous 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
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to ensure alignment with program objectives.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Is accountable for overall program process, performance, and customer satisfaction.
- Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets . Recommends new policies and procedures that affect program management. May have budget accountability for one or more programs. Program decisions are generally made only after consultation with higher level management. Innovation and
- Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties . Modifies programs management processes to improve program.
- Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team. Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans. Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management. Required Knowledge and
- Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within Medical Device Quality / Regulatory. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
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