Published: June 9, 2017
- Reports any observed or informed process and/or product non-conformities to the Supervisor for action and resolution.
- Reports any complaint regarding a product to the Supervisor.
- Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System
- Regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR’s).
- Acknowledge and maintain commitment with the EHS Policy.
- Participate in the development of EHS improvement projects.
- Participate actively in the EHS programs to achieve the objectives and targets defined for the area.
- Educational: Business Administration, Engineering or related field
- Experience: Senior Principal Level: 10+ Years with Bachelors or 7+ Years with Masters
- Exposure to supply chain, quality assurance, regulatory compliance, planning, inventory control and manufacturing environment
- Interpersonal Relations
- Quality and Results Oriented
- Computer Literate
- Fluency speaking and writing in English and Spanish
- Experience in medical device, pharmaceutical, or electronic industry
- Working knowledge of APS (Advanced Planning Systems) or MES (Manufacturing Execution Systems)
- Experience with supplier alliances, partnership agreements, supply chain management contracts and negotiating pricing & complex agreement.
- APICS, CPIM or CIRM certification
- ASQC related certification
- Problem Solving
- Continues Improvement
- Conducts strategic supply chain analysis to foster a continuous improvement environment. Identifies and recommends opportunities for improving efficiency, effectiveness, and capabilities of the supply chain. Develops and implements models, strategies and/or processes to optimize the supply chain function.
- Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management.
- Manages the development and implementation process of supply chain process and services involving departmental or cross-functional.
- Reviews status of projects and budgets; manages schedules and prepares status reports.
- Monitors the project from initiation through delivery.
- Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
- Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients.
- Provides adequate disposition to non-conforming product/ material.
- Ensures compliance with audit findings on a timely manner.
- Supports and implements special projects
- May assist qualification and validation activities for components, product or technology transfers.
- May realize capacity improvement initiatives with the industrial engineering team.
- Performs other position related duties as assigned.