For Engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT: The Technical Part:- Bachelor's Degree in Engineering or Science and eight (8) years of exposure within the Medical Devices Industry, with a strong background in field corrective actions, CAPA, or product quality management.
- Bilingual: Spanish and English
- Soft Skills: Excellent teamwork skills
- Shift: 1st, and according to business needs.
- Experience in:
- Experience in equipment IQ, OQ, and PQ and/or process validation.
- Process Validation Lifecycle.
- Preferred experience in DOE.
- Computer and software validation, SOP Development, Change control of Medical Devices
The Personality Part: - Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)- Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation.
- Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods to identify, implement, and maintain the procedures.
- Reports on the status of validation activities to fulfill regulatory requirements.
- Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
- Performs system administration and configuration of quality information technology systems.
- Quality role to support product transfer activities, focus on sterilization machines, validation, and process.
- Experience with process failure mode analysis and first-time quality.
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
- Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
- Strong project management skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
- Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
- Proficiency in quality management systems. Strong technical writing capability.
Are you the Next Piece?
