A Day in the Life Support the QMS element of CAMS deployments, primarily across LATAM, and US if required. Support the QMS/documentation requirements of Data Migration, ensuring strong technical writing and structured documentation to enable the data build team. Responsibilities Provide 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. Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Work directly with operating entities to provide process‑analysis oversight on a continuing basis to enforce requirements and meet regulations. Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors through all stages of the audits. Prepare reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provide them to applicable stakeholders, both internal and external. Coordinate legal requests in support of government investigations or litigations. Ensure the quality assurance programs and policies are maintained and modified regularly. Facilitate uniform standards worldwide and enable best‑practice sharing, thereby fostering the achievement of the company's mission globally. Nice to Have Experience supporting QMS transition projects. Experience supporting data migration activities. Understanding of maintenance or engineering processes. Experience working across multiple sites or regions. Experience supporting project go‑lives and hypercare. Exposure to continuous improvement or standardization initiatives. Specialist Career Stream Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower‑level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation – while adhering to policies and using specialized knowledge and skills normally acquired through advanced education. Differentiating Factors Autonomy : Seasoned individual contributor; works independently under limited supervision to determine and develop approaches to solutions; coaches and reviews the work of lower‑level specialists; may manage projects or processes. Organizational Impact : May be responsible for entire projects or processes within the job area; contributes to the completion of work‑group objectives through building relationships and consensus to reach agreements on assignments. Innovation and Complexity : Problems and issues faced are difficult and may require understanding of multiple issues, job areas or specialties; makes improvements to processes, systems or products to enhance performance of the job area; analysis provided is in‑depth and often provides recommendations on process improvements. Communication and Influence : Communicates with senior internal and external customers and vendors; exchanges information of facts, statuses, ideas and issues to achieve objectives and influence decision‑making. Leadership and Talent Management : May provide guidance, coaching and training to other employees within the job area; may manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience Advanced knowledge of the job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) and a minimum of 4 years of relevant experience), or an advanced degree with a minimum of 2 years of relevant experience. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. #J-18808-Ljbffr
Sr Quality Systems Spec- Temporary 12 Months
MEDTRONIC
Tijuana, Tijuana
Publicado hace 5 días
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