OUR PROJECT
Immediate opportunity to join our West Sacramento team that is developing medical systems.
This is a long-term contract position that will be onsite. You can expect competitive compensation for this position.
WHO WE ARE LOOKING FOR
We are looking for a Validation Engineer to support our growing team with their System Life Cycle, qualification and validation documentation. You will be responsible for delivering qualification documentation impacting: facilities, utilities, equipment and automation across software and equipment used to develop class I and II medical devices. Experience delivering FMEA documents is required, as is working experience with FDA 510(k) and 21 CFR Part 820 compliance and standards. At least 5 years of expertise delivering new document and change control documents is desired. Demonstrated experience in the medical devices industry is desired in this position, but experience in biologics, life science and pharmaceutical industries would be commensurate for this position. This is an excellent opportunity to support a growing team on a high-impact initiative.
We are interviewing qualified candidates immediately and will move into the offer stage quickly.
If you are interested, please apply with an updated resume.
QUALIFICATIONS
- Experience Documenting the System Life Cycle: facilities, utilities, equipment and automation
- Experience Delivering Process FMEA/Risk Management Documentation
- 5+ years of Experience with Document and Change Control delivery
- Experience performing documentation audits for FDA regulated systems
Effective written and verbal communication skills are absolutely required. All Canadian Nationals, US Citizens, and US Permanent Residents will be considered as NO SPONSORSHIP will be provided. NO 3rd PARTIES.