- 190592 - Document Control Administrator 1
- CA-Central California
- Up to $40.00 DOE
- 8 mos
- Chipton-Ross is seeking a Document Control Administrator 1 for an opening in Fremont, CA.
Process change orders (PCOs/DCOs) to support the submission of reports into MasterControl. Generate post-market surveillance plans, reports, and other required documents as required to support IVDR. Analyze and interpret clinical and PMS data. Work with project team to meet the requirements in generating PMS, Post Market Clinical Follow-up (PMCF). Assist with the post-market Risk Management process.
3-5 years of post market RA/QA affairs experience in medical device, biotech, life sciences or related fields. Excellent written and verbal communication skills working in a team environment.
Solid knowledge of GMP/FDA QSR/ISO 13485, ISO 62304, ISO 14971 and other medical device standards.
Accredited BS/BA Degree in a science related field.
Shift: M-F, 8-5
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x260 or (800) 927-9318 x260
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.