Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time
Be able to author procedures in response to corrections or corrective actions
Attention to detail
True understanding of FDA Regulations, Application of Good Laboratory Practices, and Good Manufacturing Practices
2+ years' experience in quality with a medical device/pharmaceutical company or similar regulated industry, preferred
Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools
Excellent presentation skills
Be able to stand, sit and walk throughout the work day
Bachelor's of Science in a science related field is required
Have computer proficiency with experience in Microsoft Word, Excel, and Access or other database programs
Must have computer proficiency
Excellent organizational skills
Strong knowledge of risk management, root cause analysis, corrective and preventive action and document control
This role requires extensive personnel interaction, including all functions and all levels of the organization
Ability to multi-task and work well under pressure
Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485, preferred
Ability to work effectively as part of a cross functional team
Good interpersonal/communication/influencing/negation skills
Good project management skills
Trackwise proficiency and experience is a plus
Understand scientific strategies and be able to invent new methods or new avenues of investigation