Senior Technical Manager, Ext Quality Job

SENIOR TECHNICAL MANAGER, EXT QUALITY needed for a CONTRACT opportunity with Yoh's client located in South San Francisco, CA.

WHAT YOU'LL BE DOING:

- Development and execution of risk management initiatives particularly, dFMEA and pFMEA though Phase III clinical Studies
- Participate in resolution of complaints involving Roche/Genentech products manufactured at CMO's
- Liaise with technical groups to generate, analyze data and interpret results, review and revise specifications based on design and/or process changes
- Serve as a quality subject mater expert (SME) for:
- Device and combination product Sterilization
- Packaging and shelf life studies
- Polymer materials and processing (eg silicone etc.)
- Provide quality oversight for: Device and combination product manufacturing through clinical Phases II and III
- Biocompatibility Testing for extractable, leachable and hydrolytic stability
- Support the following: Development of design verification plans, protocols, and characterization testing
- Development and execution of assembly processes and qualifications
- Ongoing assessment of CMO quality systems through clinical Phases II and III
- Facilitate investigations, root cause analysis and CAPAs of device and combination product manufacturing processes
- Develop applicable design control documents as needed
- Utilize risk management tools to identify and mitigate CMO quality and compliance risks, and ensuring CMO sites are in a state of continuous inspection readiness
- Establish quality inspection processes to ensure processes comply with the relevant requirements of the quality management system
- Consult as the Quality representative on cross-functional teams to identify and implement process and system improvements
- Provide general quality engineering support as needed

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum of five (5) years experience in end-to-end device and combination product development and commercialization.
- Must have strong background in practical application of design control, packaging and sterilization.
- The candidate must have excellent communication skills and ample experience in writing Technical Reports.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- BS in Engineering or related field, Master's degree is preferred

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Salima Hakim

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.

J2W: SCIENTIFIC; J2W: ENG

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