Quality Systems Program Mgr

Job DescriptionJob Title: Quality Systems Program ManagerClient: Medical Device Manufacturing CompanyDuration: 1 year and 7 monthsLocation: Mounds View, MN 55112Shift: 1st ShiftTechnical SkillsMust Have:5+ years of project management experienceKnowledge of 21CFR803, 21CFR820Knowledge of Medical Device Risk Management MethodologyUnderstanding of Medical Device Quality Coding for Complaint HandlingNice To Have:Experience implementing software systems for Quality ApplicationsJob DescriptionResponsibilities: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. #ZRCompany DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.