Sr Quality Systems Supv.
MedTechPharmaRegulatory AffairsQuality Assuranceemafdaiso 13485croinform
Job description
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Buscamos un Senior Quality Systems Supervisor para liderar y fortalecer nuestro sistema de calidad en planta, garantizando el cumplimiento regulatorio y la efectividad del QMS. Esta persona será responsable de supervisar procesos clave de calidad, impulsar mejoras continuas, apoyar auditorías y asegurar que la organización mantenga altos estándares de calidad, cumplimiento y seguridad del paciente. El rol también lidera talento, coordina con equipos cross-functional y contribuye a la ejecución de iniciativas estratégicas de calidad dentro de la operación. 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. Requisitos mínimos: Licenciatura o título equivalente en Ingeniería industrial, ingeniería química, ingeniería electrónica, o afines. Mínimo 6 años de experiencia relevante . Conocimientos de gestión y liderazgo. Quality & Regulatory: Conocimiento de QMS, ISO 13485, FDA/QMSR, CAPA, NC, auditorías y gestión de riesgos. Problem Solving: Capacidad para resolver problemas complejos y tomar decisiones basadas en datos y riesgo. Communication & Influence: Comunicación efectiva e influencia cross-functional y con diferentes niveles de liderazgo. English: Inglés avanzado Continuous Improvement: Experiencia en Lean/Six Sigma y mejora continua; certificaciones Green/Black Belt son un plus. Quality Culture: Capacidad para impulsar accountability, compliance y una cultura de calidad sólida. PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM: Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals. DIFFERENTIATING FACTORS Autonomy: Supervises team members or subordinate supervisors, providing tactical and / or technical leadership. May perform ongoing operational tasks. Receives assignments in task-oriented terms and delivers results according to established procedures. Organizational Impact: Plans and establishes goals and objectives for a team, typically within (1) department. Decisions impact project or department schedules, customer satisfaction levels, or allocation of time or material resources. Typically does not have budget or P&L accountability, but may manage day-to-day elements of the budget (eg, overtime for staff). Innovation and Complexity: Makes improvements to processes, systems or products. Problems and issues faced are difficult and may require understanding of broader set of issues, including multiple job areas or specialties. Communication and Influence: Communicates with internal and external customers and vendors, across various levels of the organization. Shares and exchanges relevant information to reach solutions, and gaining cooperation of other parties . Leadership and Talent Management: May be a second level supervisor of employees in the Support career stream, such as production, distribution or technicians . May be a first level supervisor of employees in the Associate or Intermediate level in the Specialist career stream . May be a first level supervisor of employees at level IV and V in the Support career stream . Leads, directs and reviews the work of team members in order to accomplish operational plans and results. Provides primary input to hiring, firing, promotion, performance and rewards decisions for direct reports. Required Knowledge and Experience: Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution. Requires advanced knowledge of job area obtained through advanced education combined with experience. 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 3 years of relevant experience, or an advanced degree with a minimum of 1 year 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. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtroni
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