Business Analyst, Validation Engineer, Senior Quality Engineer
Technical
(VAStek, Inc. has opening in San Diego, CA)
• Business Analyst: Requires MS in Computer Science, Information Technology, Management, Marketing, Management Information Systems, or closely related field & 6 months experience.
• Validation Engineer: Requires BS in Industrial Engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Engineering Management or closely related field & 3 years’ experience in Manufacturing Equipment Qualification field or MS in same or closely related field & 1 year experience in Manufacturing Equipment Qualification field. 1 year of experience is required in (1) working in an FDA regulated industry with following 21 CFR Part (11, 210, 211, 820, 54), GAMP 5, Annex 11 & e-record/e-signature std, (2) project management practices, (3) software validation & verification practices, (4) utilization of risk-based approach to validation testing. Employer will accept coursework in place of experience requirements.
• Senior Quality Engineer: Requires BS in Mechanical Engineering or related & 1 year experience. 1 year must include experience 1) in a regulated engineering industry using quality system & CAPA, 2) with medical device regulations & stds (21 CFR §820, ISO § 14971 & § 13485) & 3) performing data query & statistical analysis using software tool Minitab.
All Positions: Will work in unanticipated locations.
Send resume to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101 (refer to job title).