Responsibilities
- Perform project management responsibilities for assigned tasks on new product launches.
- Create new Device Master Record and Device History Record for the assigned manufacturing areas (documentation required for manufacturing). Prepare any other applicable documentation required for new products, processes, changes and transfers.
- Develop or revise technical documentation to specify manufacturing processes; including documentation of equipment qualification, setup and maintenance procedure.
- Coordinate and carry out qualification and validation activities for new products, processes, changes and transfers as per FDA or other applicable regulations (IQs/OQs/PQs/PPQs/TMVs). Prepare validation protocols and reports for moderate and high complexity qualifications. Participates on the definition of validation strategies.
- Conduct research and development testing and validation to determine effectiveness and compliance to quality standards for the manufacturing processes. Confirm conformance to engineering designs and methodologies and verify overall safety. Prepare reports on these activities.
- Develop and coordinate plant layout (not limited to the production floor and specific lines) and installation of new equipment, utilizing principles of ergonomics and equitable standards, to maximize efficiency.
- Coordinate engineering activities with different value streams.
- Coordinate negotiating and placing orders with vendors. Maintain vendor relations; problem solving with vendors; may recommend termination of vendor relations.
- Participate in sourcing of new machinery for production needs when necessary.
- Assess Engineering related procedures within the Company's Quality System and other systems in order to implement improvements for an optimal use and allocation of resources while maintaining compliance with the regulations.
- Act as a quality system internal auditor.
- Customer service: Direct communication with external customers, handle customer technical inquiries for specific assigned projects. Lead technical meetings with external customers.
- Perform other duties, tasks, or projects at the direction of immediate supervisor and not limited to the job category.
Education
- Bilingual English/Spanish - Advanced English level (written and spoken).
- Knowledge of applicable regulations for the medical device industry (FDA CFR 820 CGMPs, ISO 13485, etc.).
- Knowledge of Six Sigma Methodology (green belt certification) and Lean Manufacturing.
- Basic knowledge of Minitab statistical software.
Job Experience
- From 2 to 4 years of experience in a manufacturing environment.
- Experience within the medical device manufacturing or pharmaceutical fields, or any other highly regulated industry (i.e. food, aerospace, etc.) is a plus.
- Project Management experience.
- At least one year in current position.
- No disciplinary actions of less than three months.
