Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Drives improvement and corrective actions in the quality of components sourced from outside suppliers.
- Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Manufacturing/Test operations, Commercial Sourcing, Design Assurance, R&D.
- Develops solutions to a variety of complex problems of diverse scopes and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
- Plans and organizes non-routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
- Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
- Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influences middle management on business solutions.
- Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
- In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Assures that appropriate resources (personal, tools, etc.) are maintained to assure Quality System compliance and adherence to the Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality Systems.
Requirements:
- BS degree in an Engineering related field, such as: Mechanical Engineering, Materials Engineering, Chemical Engineering, Electrical Engineering, or similar technical degree with 2-4 years related experience.
- Experience in Quality Management Systems, regulatory compliance, and risk management.
- Experience with problem solving quality tools, Corrective/Preventive Actions (CAPA), Technical Documentation.
- Experience with or lead auditor certification to ISO13485, 9001, TS16949 standards.
- Ability to communicate cross functionally with suppliers, team members and leadership.
- Highly organized and detail-oriented with ability to manage multiple projects and prioritize effectively.