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Position: Manufacturing Engineer Location: San Diego, CA Duration: 06 Months+ Job Description:
- Primarily responsible for engineering support for manufacturing operations and Mfg. quality activities to at the site.
- Proven experience owning and driving projects to fruition, with a proven work ethic and consistently exceeding results.
- Proven Mfg. plant medical device product and process development experience owning and driving projects to fruition, with a proven work ethic and consistently exceeding results
- Plan, coordinate and manage all manufacturing activities associated with commercialization and launch of new medical device and pharmaceutical products.
- Medical device 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.
- 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.
- General quality control and compliance
- Expertise working in medical device manufacturing plant for medical/ pharma industry.
- Expertise in medical device technical writing of protocols, validation plans etc
- 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.
- Minimum undergraduate degree (BS) in Science, Mechanical/Industrial/Biomedical engineering
- 4Years of medical device product and process development experience in a manufacturing plant setting
- ID: #22325676
- State: California San diego 92108 San diego USA
- City: San diego
- Salary: USD 40/hr W2 All Inc 40/hr W2 All Inc
- Job type: Contract
- Showed: 2021-11-07
- Deadline: 2022-01-05
- Category: Manufacturing