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Medical Device Quality Assurance Consultant – Contract

Propharma Group, Inc.

This is a Full-time position in Boulder, CO posted July 24, 2021.

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.This is a six month contract opportunity onsite in Boulder, CO supporting a client with pre-approval inspection readiness.* Provide compliance support to client with CAPA, Change Controls, Production and Process Controls, and Supplier Quality.* Expertise with 21 CFR Part 820 regulation.* Experience with Mock FDA Audits.* 10+ years of experience with Medical Device; preferably some experience with IVDs.* Deep experience with one or more of the 4 specialty areas; CAPA, Change Controls, PP&C, and Supplier Quality.* Well versed with Quality Systems* Strong Root Cause Investigation Experience.* Experience with direct FDA facing interaction.* Experience with Mock FDA Audits.* Dynamic cross functional communication across the various work streams.* Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.* Ability to plan and manage own workAll candidates must be legally eligible to work in the United States.We are an equal opportunity employer. M/F/D/V* ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*