Vacancy expired!
Manufacturing EngineerSan diego, CA
- Manufacturing process Development and management of a transition plan and team Process documentation transfer.
- Coordination & preparation Equipment moves/ setup and installation
- Technical writing of protocols, Engineering tests as per medical device part 21 CFR Quality system
- IQ, OQ, PQ protocol development and execution support Production startup and training support.
- Is required develop technical documentation in medical device product development such as Buyspecs, Manufacturing procedures, Test methods etc.
- Is required to develop/author medical device development validation plans, test protocols etc and independently required to execute them as well.
- Work within medical device Quality system ISO13485 for execution of change controls and Design control activities
- Is required to setup/update ERP system related to new medical device product.
- Creation of documents, master data etc.
- Demonstrated proficiency in equipment and tooling procurement and process design and development (assembly and associated process development)
- Follow-up with Work Stream Leads from medical device Manufacturing Plants and to assimilate project information daily
- Understanding and ability to execute DOEs, process validations and process characterizations for medical device process development
- Creates and reviews risk assessments and FMEA
- Oversees and is accountable for overall compliance administration activities relating to QSR, design controls, validations and CAPA
- Provides support for project teams or Quality department as required.
- Provides work direction as required.
- Creates and reviews quality system documentation.
- Maintains validation master plan.
- Builds protocols, test methods, Product validations
- Performs supplier quality system audits.
- Strong interpersonal skills required in the areas of verbal and written communications, time management and professionalism
- Strong information management skills.
- Strong analytical thinking, questioning & problem-solving skills.
- ID: #23852571
- State: California San diego 92101 San diego USA
- City: San diego
- Salary: Depends on Experience
- Job type: Contract
- Showed: 2021-12-04
- Deadline: 2022-01-31
- Category: Et cetera