About the Company:
Our client is a medium sized medical device company focused on surgical devices headquartered in Irvine, CA.
Our client produces and manufacturers an array of products ranging in different Surgical devices
This role will start 9/21, and will go permanent after 6 months.
About the Role:
Working in a large, but collaborative group of QA/Validation professionals; you will be responsible for maintaining validation program activities including generating protocols, reports and execution of process and equipment validations/qualifications. You will be responsible for Master Validation Plans, validation standards, IQ, OQ, PQ. SQs, DOEs, and GR&Rs. You will be working primarily with new, and sustaining activities associates with products, processes, and equipment.
You will be a core team member working directly with the Director of QA/RA, and will be a member of a team of 30 other QA professionals.
You will be working in medium to large company, and will be working in a fast paced environment.
Your skills and experience
- Bachelor's degree preferable in engineering, or life science (or relevant working experience).
- Minimum of 2 years of experience in a regulated QSR environment conducting Quality or Validation Engineering activities (medical device, aerospace, or automotive).
- Proficient in flow diagrams, PFMEAs, DOEs.
- Experience with Manufacturing of electromechanical products preferred.
You are a positive person that is an over-communicator. You are a team player who enjoys working in a cross functional team, and in a collaborative environment. You have strong communication, social skills, and Quality/Validation Engineering experience in an industrial engineering/regulated environment. You have worked in the medical device, aerospace, or automotive industries, and are interested in a collaborative, multi-functional, and fast paced environment.
Sthree US is acting as an Employment Business in relation to this vacancy.