Quality Systems Program Mgr

Juncos, PR
Permanente
Tiempo completo

Hace 6 días

Responsibilities may include the following and other duties may be assigned. 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 provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. 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 one job area. 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 Bachelor's degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.What are the top 3 things you are looking for in a candidates experience:
1. Hands on Experience on Projects/Scheduling for Medical Device manufacturing
2. Excellent Negotiating and Communication Skills
3. Risk Management/Critical Thinking
4. Conflict Resolution skills
5. Knowledge in Medical Devices regulationsEducation: Engineering degree (preferable); Sciences
Years’ Experience Required: 5+plus yrs **Weil Group is proud to be an Equal Employment Opportunity Employer.*

Weil Group

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